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Edwards Lifesciences, LLC

Edwards Lifesciences, LLC Recalls

All product recalls associated with Edwards Lifesciences, LLC.

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Recall Summary

Total Recalls

60

Past Year

3

Class I (Serious)

0

Most Recent

May 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 60 recalls

Edwards Lifesciences, LLC: Edwards REF: VJ0990, Blood Management System, Rx Only, Si...

There is a potential that the pressure tubing may detach from the blood sampling system

FDAMay 26, 2021AZ, CA, CO +30 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF:...

There is a potential that the pressure tubing may detach from the blood sampling system

FDAMay 26, 2021AZ, CA, CO +30 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: ...

There is a potential that the pressure tubing may detach from the blood sampling system

FDAMay 26, 2021AZ, CA, CO +30 more• Edwards Lifesciences, LLC

Page 2 of 3Next

Edwards Lifesciences, LLC: Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure M...

There is a potential that the pressure tubing may detach from the blood sampling system

FDAMay 26, 2021AZ, CA, CO +30 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Manageme...

There is a potential that the pressure tubing may detach from the blood sampling system

FDAMay 26, 2021AZ, CA, CO +30 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Sterile Oxymetry Oligon Catheter Kit. Pressure injectable...

Sterile catheter kit packaging compromised.

FDAMar 27, 2020AZ, CA, FL +12 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699;...

If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.

FDANov 27, 2019AL, AZ, AR +38 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8")...

Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.

FDAOct 22, 2019Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)006901031...

Intermittent communication due to inconsistent crimping of connectors onto cables.

FDAOct 7, 2019Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (...

The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

FDAJul 9, 2019AL, CA, GA +9 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10...

Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.

FDAMay 14, 2019Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edwards Lifesciences Vent Catheters, . Packaged sterile a...

Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.

Class IIModerate

FDAOct 8, 2014AL, AZ, AR +42 more• Edwards Lifesciences, LLC

Edwards Lifesciences Research Medical, Inc.: EndoClamp aortic catheter. Label reading in part: "***CAR...

Balloon catheters were spontaneously rupturing during use.

FDASep 24, 2009Nationwide• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: EndoClamp aortic catheter label reading in part: "CARDIOV...

Spontaneous balloon rupture during use of the product.

FDASep 24, 2009Nationwide• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences, Llc: Edwards Lifesciences Fogaty Occlusion Catheter Ref # 6208...

Several complaints were the two parts of the tubular package became loose under the shrink wrap that holds the DFU on the packaging tube.

FDAJun 22, 2009AL, AZ, AR +44 more• Edwards Lifesciences, Llc

Edwards Lifesciences, Llc: Edwards LifeSciences, Percutaneous Sheath Introducer Set,...

Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.

FDAMay 11, 2009Nationwide• Edwards Lifesciences, Llc

Edwards Lifesciences, Llc: Edwards Lifesciences Aquarius System Model GEF09800.

There have been reports of clinically significant fluid imbalance when a certain level of fluid imbalance is detected the Aquarius will trigger an alarm, however, users are able to override this alarm and continue therapy. It is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this may result in serious injuries or death.

FDAMar 16, 2009Nationwide• Edwards Lifesciences, Llc

Edwards Lifesciences, Llc: Edwards Lifesciences Swan-Ganz Thermodilution Catheter RE...

Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".

FDAFeb 9, 2009AL, AZ, AR +37 more• Edwards Lifesciences, Llc

Edwards Lifesciences Research Medical, Inc.: CardioVations Ethicon, a Johnson and Johnson company, End...

Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.

FDANov 26, 2008AL, AK, CA +32 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Edwards Lifesciences CardioVations, EndoClamp aortic cath...

Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.

FDANov 26, 2008AL, AK, CA +32 more• Edwards Lifesciences Research Medical, Inc.