The Recall Desk

Manufacturer

Edwards Lifesciences, LLC

95 recalls in our database name Edwards Lifesciences, LLC as the manufacturing or recalling firm.

What the numbers show

Total
95
Critical
4
Severe
15
Most recent
2026-05-20

Of the 95 recalls from Edwards Lifesciences, LLC we have scored against our rubric, 4 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (16%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 95

  • CriticalFDA (Devices)·Z-0764-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error

    Edwards Lifesciences is recalling 9 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0763-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

    Edwards Lifesciences is recalling 875 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac o
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0762-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error

    Edwards Lifesciences is recalling 277 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2435-2018·2018-07-25

    Edwards SAPIEN 3 Transcatheter Heart Valve Recalled for Incorrect Size Labeling

    Edwards Lifesciences is recalling one SAPIEN 3 Transcatheter Heart Valve because it was packaged with the incorrect valve size relative to the label.

    Product
    Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1929-2018·2018-05-30

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak

    Edwards Lifesciences is recalling 3,052 IntraClude Intra-Aortic Occlusion Devices due to a possible leak at the distal open end of the strain relief.

    Product
    Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0496-2018·2018-02-07

    Edwards HemoSphere System Recalled for Pre-Procedural Software Defects

    Edwards Lifesciences is recalling 198 HemoSphere System devices due to pre-procedural software defects. The devices are distributed in 11 US states.

    Product
    Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2018·2018-01-17

    Edwards Certitude Delivery System Recalled for Molding Overflow Defect

    Edwards Lifesciences is recalling 1,730 units of the Certitude Delivery System due to a molding overflow defect that could detach and embolize into patients.

    Product
    Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) o
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-3077-2017·2017-09-06

    Edwards Lifesciences Recalls Fogarty Adherent Clot Catheters Due to Balloon Size Error

    Edwards Lifesciences is recalling specific Fogarty Adherent Clot Catheters because the balloon diameter measures 6mm instead of the intended 10mm.

    Product
    Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0446-2016·2015-12-23

    Edwards Lifesciences Recalls IV Administration Sets for Regulatory Submission

    Edwards Lifesciences is recalling 147,350 units of IV Administration Sets because an additional FDA submission is required to support commercialization.

    Product
    Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0398-2016·2015-12-16

    Edwards Thin-Flex Venous Cannula Recalled for Incorrect Connector Size Labeling

    Edwards Lifesciences is recalling Thin-Flex Venous Cannulas because the product guide incorrectly lists the connector size as 3/8 inch instead of the actual 1/2 inch.

    Product
    Thin-Flex Venous Cannula, Model Number:TF292902A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2015·2015-09-30

    Edwards Lifesciences Recalls ThruPort Knot Pusher Due to Suture Fraying Risk

    Edwards Lifesciences is recalling 759 ThruPort Knot Pusher units because the device's tip design may cause suture fraying or splitting, potentially compromising suture knot integrity during cardiac surgery.

    Product
    ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2015·2015-06-17

    Edwards Lifesciences Recalls ClearSight Heart Reference Sensor Due to Damage

    Edwards Lifesciences is recalling ClearSight Heart Reference Sensors because the finger component may be damaged. The recall affects 1,309 units distributed worldwide.

    Product
    ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2015·2015-06-17

    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to potential damage near the hub that may cause blood leakage.

    Product
    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1700-2015·2015-06-10

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Heparin Activity Failure

    Edwards Lifesciences is recalling 978 Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters because they failed internal statistical tests for heparin activity.

    Product
    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2015·2015-04-08

    Edwards Lifesciences Recalls Fem-Flex II Pediatric Femoral Arterial Cannulas

    Edwards Lifesciences is recalling specific sizes of the Fem-Flex II Pediatric Femoral Arterial Cannula due to a protruding wire at the tip that could cause tissue damage.

    Product
    Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0217-2015·2014-11-26

    Edwards Lifesciences Recalls Vent Catheters Due to Stylet Coating Disruption

    Edwards Lifesciences is recalling Vent Catheters because the white plastic coating on the stylet may disrupt. The action covers 157,305 units distributed worldwide.

    Product
    Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventr
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1466-2014·2014-04-23

    Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation

    Edwards Lifesciences is recalling 13,115 Fem-Flex II Arterial and femoral Cannulae because the dilator tips may separate. The recall covers units distributed nationwide and to foreign, government, and military consignees.

    Product
    Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2014·2014-04-23

    Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation

    Edwards Lifesciences is recalling 28,885 Fem-Flex II Arterial and Femoral Cannulae because the dilator tips may separate.

    Product
    Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2014·2014-02-12

    Edwards Lifesciences Recalls 26mm Transcatheter Heart Valve Crimpers

    Edwards Lifesciences is recalling two lots of 26mm transcatheter heart valve crimpers because they may not open fully, potentially preventing proper valve preparation.

    Product
    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0560-2014·2014-01-01

    Edwards Lifesciences Recalls Mislabelled Ergonic Double Acting DeBakey Forceps

    Edwards Lifesciences is recalling three units of Ergonic Double Acting DeBakey Forceps due to incorrect laser etching that misidentified the instrument type.

    Product
    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0135-2014·2013-11-13

    Edwards Lifesciences Recalls Aortic Perfusion Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of aortic perfusion cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Ao
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2014·2013-11-13

    Edwards Lifesciences Recalls Fem-Flex Femoral Arterial Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of Fem-Flex Femoral Arterial Cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0091-2014·2013-11-06

    Edwards Lifesciences Recalls EMBOL-X Glide Protection System Due to Deformation

    Edwards Lifesciences is recalling EMBOL-X Glide Protection Systems because the cannula tip may deform. The recall covers 12,034 units distributed in the US and Canada.

    Product
    Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2189-2013·2013-09-18

    Edwards Lifesciences Recalls FloTrac Sensor Due to Packaging Error

    Edwards Lifesciences is recalling 35 units of the FloTrac Sensor Model MHD85 because incorrect packaging configuration prevents validation of the product's sterility.

    Product
    "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2013·2013-08-21

    Edwards Lifesciences Recalls Anastaflo Intravascular Shunts Due to Adhesive Concerns

    Edwards Lifesciences is recalling specific lots of Anastaflo intravascular shunts because excessive adhesive on the shunt body may interfere with suturing during bypass graft construction.

    Product
    Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Edwards Lifesciences

American medical technology company

Country
United States
Founded
1956

Official website

Source: Wikidata (Q16966841), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.