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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 11-K

ANNUAL REPORT PURSUANT TO SECTION 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934

ý Annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934

For the fiscal year ended December 31, 2001

OR

o Transition report pursuant to Section 15(d) of the Securities Exchange Act of 1934

For the transition period from              to             

Commission file number 1-15525

A.    Full title of the plan and the address of the plan, if different from that of the issuer named below:

Edwards Lifesciences Corporation
401(k) Savings and Investment Plan

B.    Name of issuer of the securities held pursuant to the plan and the address of its principal executive office:

Edwards Lifesciences Corporation
One Edwards Way
Irvine, California 92614
(949) 250-2500


Edwards Lifesciences Corporation
401(k) Savings and Investment Plan
Index to Financial Statements and Supplemental Schedule

 
   Page
Report of Independent Accountants   1
Financial Statements:    
  Statements of Net Assets Available for Benefits as of December 31, 2001 and 2000   2
  Statements of Changes in Net Assets Available for Benefits for the year ended December 31, 2001 and the period from April 1, 2000 (Inception) to December 31, 2000   3
  Notes to Financial Statements   4
Supplemental Schedule:*    
  Schedule H-line 4i-Schedule of Assets (Held at End of Year)   9
Signature   10
Consent of Independent Accountants   11
*
Other schedules required by Section 2520.103-10 of the Department of Labor Rules and Regulations for Reporting and Disclosure under ERISA have been omitted because they are not applicable.


Report of Independent Accountants

To the Administrative and Investment Committee for the
    Edwards Lifesciences Corporation
    Employee Benefit Plans:

        In our opinion, the accompanying statements of net assets available for benefits and the related statements of changes in net assets available for benefits present fairly, in all material respects, the net assets available for benefits of the Edwards Lifesciences Corporation 401(k) Savings and Investment Plan (the "Plan") at December 31, 2001 and 2000, and the changes in net assets available for benefits for the year ended December 31, 2001 and the period from April 1, 2000 (inception) to December 31, 2000 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Plan's management; our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with auditing standards generally accepted in the United States of America, which require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

        Our audits were conducted for the purpose of forming an opinion on the basic financial statements taken as a whole. The supplemental Schedule of Assets (Held at End of Year) is presented for the purpose of additional analysis and is not a required part of the basic financial statements but is supplementary information required by the Department of Labor's Rules and Regulations for Reporting and Disclosure under the Employee Retirement Income Security Act of 1974. This supplemental schedule is the responsibility of the Plan's management. The supplemental schedule has been subjected to the auditing procedures applied in the audit of the basic financial statements and, in our opinion, is fairly stated in all material respects in relation to the basic financial statements taken as a whole.

/s/ PricewaterhouseCoopers LLP

Orange County, California
June 28, 2002

1


Edwards Lifesciences Corporation
401(k) Savings and Investment Plan
Statements of Net Assets Available for Plan Benefits

 
   December 31,
  
 
   2001
   2000
  
Investments, at fair value and cash equivalents   $ 94,311,704   $ 107,225,078  
Group annuity contracts, at contract value     33,565,608     25,569,034  
   
 
 
   
Total investments
 
 
127,877,312
 
 
132,794,112
 
   
 
 

Receivables:
 
 
 
 
 
 
 
  Dividends and interest receivable     323,874     240,947  
  Participant contributions     51,513     50,513  
  Company contributions     880,384     25,976  
   
 
 
   
Total receivables
 
 
1,255,771
 
 
317,436
 
   
 
 
    Total assets     129,133,083     133,111,548  

Accounts payable and cash equivalents
 
 
(131,734
)
 
(129,335
)
Due to brokers for securities purchased and cash equivalents     (823,174 )   (51,864 )
   
 
 
   
Net assets available for benefits
 
$
128,178,175
 
$
132,930,349
 
   
 
 

The accompanying notes are an integral part of these financial statements.

2


Edwards Lifesciences Corporation
401(k) Savings and Investment Plan
Statements of Changes in Net Assets Available for Benefits

 
   Year Ended
December 31, 2001
   Period From
April 1, 2000
(Inception) to
December 31, 2000
  
Additions to net assets:              

Investment income:
 
 
 
 
 
 
 
  Interest   $ 2,077,687   $ 1,381,558  
  Dividends     185,147     235,163  
   
 
 
    Total investment income     2,262,834     1,616,721  
   
 
 

Net appreciation (depreciation) in fair value of assets
 
 
2,212,933
 
 
(234,347
)
   
 
 

Contributions:
 
 
 
 
 
 
 
  Participant contributions     7,892,106     6,712,257  
  Company contributions     5,678,456     2,790,974  
  Rollover contributions     770,238     708,807  
   
 
 
    Total contributions     14,340,800     10,212,038  
   
 
 

Transfers from other plans
 
 
—
 
 
129,917,719
 
   
 
 
    Total additions     18,816,567     141,512,131  
   
 
 

Deductions from net assets:
 
 
 
 
 
 
 

Benefits paid to participants
 
 
(23,118,024
)
 
(5,839,975
)
Administrative expenses     (450,717 )   (329,192 )
Transfers to other plans     —     (2,390,177 )
Other     —     (22,438 )
   
 
 
    Total deductions     (23,568,741 )   (8,581,782 )
   
 
 

Net (decrease) increase
 
 
(4,752,174
)
 
132,930,349
 
Net assets available for benefits              
  Beginning of period     132,930,349     —  
   
 
 
  End of year   $ 128,178,175   $ 132,930,349  
   
 
 

The accompanying notes are an integral part of these financial statements.

3


Edwards Lifesciences Corporation
401(k) Savings and Investment Plan
Notes to Financial Statements

1.  Description of the Plan

        The following description of the Edwards Lifesciences Corporation 401(k) Savings and Investment Plan (the "Plan") is provided for general information purposes only. The Plan was created effective April 1, 2000 in connection with the spin-off of Edwards Lifesciences Corporation (the "Company") from Baxter International Inc. ("Baxter"). The Baxter International Inc. and Subsidiaries Investment Incentive Plan assets relating to the Company's U.S. employees were transferred to the Plan at the time of the spin-off. In September 2000, $2,390,177 was transferred out of the Plan's assets as a result of the Company's sale of its Novacor and Bentley product lines. Participants should refer to the Plan document for more complete information.

General

        The Plan is a defined contribution retirement plan subject to the provisions of the Employee Retirement Income Security Act of 1974, as amended ("ERISA"). Participation in the Plan is available to employees of the Company who have met certain eligibility requirements, as described below.

Eligibility

        Employees become eligible to participate in the Plan on the first day of the month following one full month of employment. Eligible individuals are those who are U.S. employees of the Company, or a subsidiary, division or facility of the Company that has adopted the Plan, other than:

Plan Administration

        The Plan is administered by the Administrative and Investment Committee for the Edwards Lifesciences Corporation Employee Benefit Plans (the "Committee"). The Committee has authority, responsibility and control over the management of the assets of the Plan. Members of the Committee are appointed by the Board of Directors of the Company and are currently employees of the Company. State Street Bank and Trust Company ("Trustee") serves as trustee of the Plan assets and CitiStreet Institutional and Total Benefits Outsourcing provides record keeping services for the Plan.

Contributions

        The Plan allows tax deferred contributions intended to qualify under Section 401(k) of the Internal Revenue Code ("IRC"). Eligible participants may make pre-tax contributions up to 15% of their eligible annual compensation within certain limitations. The Company matches the first three percent of the participant's annual eligible compensation contributed to the Plan on a dollar for dollar basis. The Company matches the next two percent of the participant's annual eligible compensation to the Plan on a 50% basis. In addition, each participant who is an hourly manufacturing employee is eligible to receive discretionary profit sharing contributions in an amount targeted at three percent of such

4


participant's annual base pay based on the achievement of certain performance measures. Further, each participant who was an hourly manufacturing employee and whose employment was transferred as of March 31, 2000 to the Company from Baxter was credited with an initial contribution of 50 shares of the Company's common stock. Also, certain employees are eligible for transitional contributions related to the spin-off from Baxter, as described more fully in the Plan.

Participant Accounts

        Each participant's account is credited with the participant's contributions, the Company's matching contributions and the allocation of the participant's share of the Plan's net earnings and losses, net of certain investment management fees. Allocations are based on participant account balances, as defined.

Vesting

        Participants are immediately fully vested in their plan accounts (other than their Company matching contributions) plus actual earnings thereon. Vesting in a participant's Company matching contributions plus actual earnings thereon is based on years of continuous service. A participant vests in Company matching contributions in annual increments of 20% and, therefore, is 100% vested after five years of credited service. On termination of service due to death, disability, or attainment of normal retirement age, a participant shall become fully vested.

Investment Options

        Upon enrollment in the Plan, a participant may direct contributions in any of the following investment options:

5

Participant Loans

        Participants may borrow an amount ranging from a minimum of $500 up to a maximum equal to the lesser of $50,000 or 50% of their vested account balances. The loans bear interest based on the applicable prime rate at the time of issuance plus 1%, which interest rates presently range from 5.75% to 10.50%, and have a maximum term of five years (or ten years if used to acquire a home). The loans are collateralized by the participants' vested interest in their accounts and any additional collateral as the Committee may require. Principal and interest are generally paid ratably through payroll deductions.

Payment of Benefits

        On termination of service or otherwise becoming eligible to receive benefits, a participant may elect to receive a lump-sum amount equal to the value of the participant's account or periodic installments or to transfer the balance in the participant's account to another qualified plan. Vested accounts of $5,000 or less will be automatically paid in a lump-sum amount.

        A participant may make withdrawals from the participant's accounts (except as provided in the Plan document) upon reaching age 591/2, becoming fully vested and completing five years of Plan participation. Withdrawals may also be made for financial hardship, which is determined pursuant to the provisions of the IRC. Upon making a hardship withdrawal, a participant may not make additional pre-tax contributions for a period of 12 months from the date of the withdrawal payment.

Administrative Expenses

        Substantially all investment manager, trustee and administrative fees incurred in the administration of the Plan were paid from the assets of the Plan.

Forfeitures

        A participant's nonvested balance is forfeited at the time of termination of employment. Such forfeitures may be used to offset future Company matching contributions.

2.    Summary of Significant Accounting Policies

Basis of Accounting

        The accompanying financial statements of the Plan have been prepared on the accrual basis of accounting in conformity with accounting principles generally accepted in the United States of America.

Investment Valuation and Income Recognition

        Investments in commingled funds are valued based on information provided by the Trustee. The value ascribed by the Trustee is based on closing prices of the underlying securities on the valuation date. The financial statements of the commingled funds are audited annually by independent accountants.

        Investments in mutual funds are valued based on the closing market price on the valuation date.

        Investments in common stock are valued based on the closing stock price on the valuation date.

6


        Group annuity contracts are valued based on contract value, as reported to the Plan. Contract value represents contributions plus interest earned less benefits paid and transfers to other funds.

        Participant loans are valued at the unpaid principal amount of the loan, which is estimated to approximate fair value.

        Purchases and sales of securities are reflected on a trade date basis. Interest income is recorded on an accrual basis. Dividend income is recorded on the ex-dividend date. The Plan presents in the statement of changes in net assets available for benefits the net appreciation (depreciation) in the fair value of its investments which consists of the realized gains or losses and unrealized appreciation (depreciation) on those investments.

        The assets of the Plan are held in a master trust. Net assets, investment income, and gains and losses are allocated to the Plan based on its proportionate share of the master trust. The Plan's proportionate interest in the master trust at December 31, 2001 and 2000 was 96% and 97%, respectively.

Payment of Benefits

        Benefits to participants are recorded when paid.

Use of Estimates

        The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the financial statements and related notes to the financial statements. Changes in such estimates may affect amounts reported in future periods.

Risks and Uncertainties

        The Plan provides for various investment options in any combination of investment securities. Investment securities are exposed to various risks, such as interest rate, market and credit. Due to the level of risk associated with certain investment securities and the level of uncertainty related to changes in the value of investment securities, it is at least reasonably possible that changes in risks in the near term would materially affect participants' account balances and the amounts reported in the statements of net assets available for benefits and the statements of changes in net assets available for benefits.

3.    Group Annuity Contracts

        From April 1, 2000 until March 6, 2001, the Stable Value Fund (the "Fund") held an investment in a group annuity contract directly with Deutsche Morgan Grenfell. At December 31, 2000, in accordance with Statement of Position 94-4, this fund was reported in the financial statements at contract value as the investments were considered fully benefit responsive. There were no reserves charged against the contract value for credit risk of the contract issuer or otherwise. The average yield and crediting interest rates were approximately 4.8% and 6.11%, respectively, for the year ended December 31, 2000.

        In addition, the Fund holds units of participation in a commingled fund comprised of various investment contracts that are reported in the financial statements at contract value as the investments are considered fully benefit responsive.

7


4.    Investments

        Investments representing five percent or more of the Plan's net assets are summarized as follows:

 
   December 31,
2001
   December 31,
2000
Principal Accumulation Return Fund   $ 33,565,609   $ —
US Growth & Income Fund Series A     18,935,875     24,775,164
S&P 500 Flagship Fund Series A     20,952,933     37,133,275
Passive Bond Market Index Securities Lending Fund Series A     12,671,733     —
Baxter International Inc. Common Stock     17,610,856     17,236,698
Edwards Lifesciences Corporation Common Stock     15,595,867     10,852,217
Group Annuity Contract with Deutsche     —     21,522,376

        The Plan's investments (including gains and losses on investments bought and sold, as well as held during the year) appreciated (depreciated) in value as follows:

 
   Year Ended
December 31, 2001
   Period From
April 1, 2000
(Inception) to
December 31, 2000
  
Common stock   $ 9,830,660   $ 6,987,337  
Commingled investments     (7,423,217 )   (7,221,684 )
Mutual Funds     (194,510 )   —  
   
 
 
    $ 2,212,933   $ (234,347 )
   
 
 

5.    Distribution Priorities upon Termination of the Plan

        Although it has not expressed any intent to do so, the Company has the right under the Plan to reduce, suspend or discontinue its contributions at any time and to terminate the Plan subject to the provisions of ERISA. Upon termination of the Plan, the account balance of each participant will become 100% vested and all assets, net of expenses, will be distributed to the participants or the participants' beneficiaries.

6.    Tax Status of the Plan

        The Company has received a favorable determination letter from the Internal Revenue Service on the Plan's federal income tax status. Although the Plan has since been amended, the Plan Administrator believes the Plan is currently designed and is being operated in compliance with the applicable requirements of the Internal Revenue Code.

7.    Related Parties

        At December 31, 2001 and 2000, the Plan held units of participation in certain commingled funds and short-term investment funds of the Trustee and held shares of common stock of the Company. These transactions are allowable party-in-interest transactions under ERISA and the regulations promulgated thereunder.

8



Edwards Lifesciences Corporation
401(k) Savings and Investment Plan
Schedule H-line 4i-Schedule of Assets (Held at End of Year)
As of December 31, 2001


(a)
 (b) Identity of issue, borrower,
lessor or similar party
   (c) Description of investment including maturity date,
rate of interest, collateral, par or maturity value
   (d) Cost
   (e) Current
Value
* State Street Bank & Trust   Short term investment fund       $ 150,631
* State Street Bank & Trust   S&P 500 Flagship Fund Series A         20,952,933
* State Street Bank & Trust   U.S. Growth and Income Fund Series A         18,935,875
* State Street Bank & Trust   Passive Bond Market Index Securities Lending Fund Series A         12,671,733
* State Street Bank & Trust   Daily EAFE Securities Lending Fund A         3,260,085
* State Street Bank & Trust   Principal Accumulation Return Fund         33,565,609
* State Street Bank & Trust   Russell 2000 Index Securities Lending Fund         347,994
  Ameristock   Ameristock Mutual Fund         12,727
  Bridgeway   Bridgeway Aggressive Growth         5,557
  Citizens Funds   Citizens Global Equity         12,635
  Pacific Financial Research   Clipper         63,925
  Credit Suisse   Credit Suisse Capital Appreciation         4,700
  Dodge & Cox   Dodge & Cox Stock         42,564
  Dreyfus   Dreyfus Aggressive Value Fund         8,064
  Dreyfus   Dreyfus Mid Cap Value Fund         5,824
  Fidelity   Spartan US Equity Index         1,386
  Fidelity   Fidelity International Bond         2,933
  Fidelity   Fidelity Mid Cap Stock         8,022
  Fidelity   Fidelity Equity Income         507
  Fidelity   Fidelity Growth Company         6,007
  Fidelity   Fidelity Dividend Growth         1,459
  Fidelity   Fidelity Value         3,825
  Firsthand   Firsthand Technology Value         28,354
  Gabelli Funds   Gabelli Global Growth Fund         10,024
  Gabelli Funds   Gabelli Growth         453
  Invesco   Invesco Dynamics         9,334
  Invesco   Invesco Energy         3,962
  Invesco   Invesco Health Sciences         11,679
  Invesco   Invesco Technology Class C         3,826
  Invesco   Invesco Total Return         3,734
  Janus   Janus Growth and Income         48,535
  Morgan Stanley   Morgan Stanley Institutional Small Cap Value         10,365
  Morgan Stanley   Morgan Stanley Inst Mid Cap Growth         6,179
  Neuberger Berman   Neuberger Berman Focus Trust Class         6,530
  Oak Associates Funds   White Oak Growth Stock         10,360
  PBHG Funds   PBHG Large Cap Growth         8,121
  T. Rowe Price   T. Rowe Price Growth Stock         9,087
  T. Rowe Price   T. Rowe Price Value         9,416
  Royce Funds   Royce Total Return Fund         3,177
  State Street Bank & Trust   SSGA Money Market Fund         172,647
  Selected Funds   Selected American Shares         108,419
  Strong Funds   Strong Opportunity Income         49,311
  Strong Funds   Strong Large Cap Growth         7,365
  Tocqueville Trust   Tocqueville Small Cap Value         5,301
  Tweedy Brown   Tweedy Brown Global Value Fund         42,400
  Value Line Mutual Funds   Value Line Special Situation Inc         14,478
  Vanguard   Vanguard US Growth Portfolio         418
  Vanguard   Vanguard Growth and Income         7,400
  Vanguard   Vanguard Morgan Growth         6,729
  Vanguard   Vanguard Windsor II         6,602
  Vanguard   Vanguard Index Trust S&P 500 Port         13,222
  Wasatch Funds   Wasatch Small Cap Growth         4,192
  Weitz Funds   Weitz Partners Value         3,368
  Weitz Funds   Weitz Value         5,234
  Baxter International Inc.   314,815 shares of common stock         17,610,856
* Edwards Lifesciences Corp.   547,461 shares of common stock         15,595,867
* Participant Loans   Varying maturity dates with interest rates ranging from 5.75% to 10.50%         3,975,372
             
              $ 127,877,312
             
*
Party-in-interest

9


SIGNATURE

        The Plan.    Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the administrator of the Plan has duly caused this annual report to be signed on its behalf by the undersigned hereunto duly authorized.

    EDWARDS LIFESCIENCES CORPORATION
401(K) SAVINGS AND INVESTMENT PLAN

 
 
By:
/s/  BRUCE J. BENTCOVER      
      Bruce J. Bentcover
Member of the Administrative and
Investment Committee for the
Edwards Lifesciences Corporation
Employee Benefit Plans

July 1, 2002

10




QuickLinks

Edwards Lifesciences Corporation 401(k) Savings and Investment Plan Index to Financial Statements and Supplemental Schedule
Report of Independent Accountants
Edwards Lifesciences Corporation 401(k) Savings and Investment Plan Statements of Net Assets Available for Plan Benefits
Edwards Lifesciences Corporation 401(k) Savings and Investment Plan Statements of Changes in Net Assets Available for Benefits
Edwards Lifesciences Corporation 401(k) Savings and Investment Plan Notes to Financial Statements
Edwards Lifesciences Corporation 401(k) Savings and Investment Plan Schedule H-line 4i-Schedule of Assets (Held at End of Year) As of December 31, 2001
SIGNATURE