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.

76–95 of 95

  • HighFDA (Devices)·Z-1972-2013·2013-08-21

    Edwards Recalls EndoReturn Arterial Cannula Due to Component Error

    Edwards Lifesciences is recalling specific lots of the EndoReturn Arterial Cannula because an incorrect component was used, which may cause performance issues with the IntraClude device.

    Product
    Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2013·2013-07-24

    Edwards Lifesciences Recalls Suction Wands Due to Plastic Particulate

    Edwards Lifesciences is recalling specific models of rigid suction wands because plastic particulate was found inside the sterile pouch and within the wand.

    Product
    Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2013·2013-06-19

    Edwards Recalls QuickDraw Venous Cannula Due to Separation Complaints

    Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate during withdrawal when using the percutaneous insertion method.

    Product
    QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one ship
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2013·2013-05-22

    Edwards Lifesciences Recalls Proplege Coronary Sinus Catheters Due to Leakage

    Edwards Lifesciences is recalling Proplege Coronary Sinus Catheters, model PR9, because of confirmed blood leakage through the hemostasis valve in the kitted introducer.

    Product
    Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2013·2013-04-24

    Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes

    Edwards Lifesciences is recalling 6,117 units of Model 9100CR26 Crimpers because holes in the sterile barrier pouch may compromise sterility.

    Product
    Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2013·2013-04-24

    Edwards Lifesciences Recalls Duraflo Coated Femoral Cannula Due to Sealing Defect

    Edwards Lifesciences is recalling 379 units of Duraflo coated Femoral Cannula because two unsealed pouches were found at a distribution location, posing a sterility risk.

    Product
    Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2013·2013-04-24

    Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes

    Edwards Lifesciences is recalling 5,472 units of Model 9100CR23 Crimpers because holes in the sterile barrier pouch may compromise sterility.

    Product
    Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2013·2013-04-24

    Edwards Lifesciences Recalls Pressure Monitoring Sets with VAMP Plus System

    Edwards Lifesciences is recalling Pressure Monitoring sets with VAMP Plus closed blood sampling systems due to incorrect assembly that may dilute blood samples.

    Product
    Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2012·2012-07-18

    Edwards Lifesciences Recalls Rigid Suction Wands Due to Tip Detachment Risk

    Edwards Lifesciences is recalling Rigid Suction Wands (models S033 and SPC2081) because the plastic tip may detach during use.

    Product
    Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular invol
    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.