Recall Record

Irvine, CA, United States

Edwards Lifesciences, LLC recalls

25 recalls recorded since 2018, most recently on 27 March 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.

Recalls25
Ongoing (FDA)9
Terminated or completed16
Class I (FDA)7

Ongoing Class II Medical devices

Recall started
27 March 2026
Reason
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Distribution
Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom.
Initiated
Voluntary: Firm initiated
Recall number
Z-2172-2026

Ongoing Class I Medical devices

Recall started
14 May 2025
Reason
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Distribution
Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESO
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2080-2025, Z-2083-2025, Z-2084-2025, Z-2082-2025, Z-2085-2025, Z-2081-2025

Ongoing Class II Medical devices

Recall started
4 October 2023
Reason
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe I
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0410-2024, Z-0413-2024, Z-0411-2024, Z-0414-2024, Z-0412-2024, Z-0409-2024

Ongoing Class II Medical devices

Recall started
7 September 2023
Reason
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Distribution
OUS: Singapore, Taiwan, Canada
Initiated
Voluntary: Firm initiated
Recall number
Z-0238-2024

Ongoing Class II Medical devices

Recall started
27 July 2023
Reason
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.
Distribution
International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.
Initiated
Voluntary: Firm initiated
Recall number
Z-2479-2023

Ongoing Class II Medical devices

Recall started
14 February 2023
Reason
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1380-2023, Z-1379-2023

Ongoing Class II Medical devices

Recall started
6 October 2022
Reason
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0146-2023, Z-0147-2023

Ongoing Class II Medical devices

Recall started
1 March 2022
Reason
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina,
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0834-2022, Z-0835-2022

Terminated Class II Medical devices

Recall started
9 July 2021
Terminated
29 January 2024
Reason
There is a potential for internal leaks within catheters.
Distribution
US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2283-2021, Z-2281-2021, Z-2278-2021, Z-2279-2021, Z-2282-2021, Z-2280-2021

Terminated Class II Medical devices

Recall started
26 May 2021
Terminated
14 December 2023
Reason
There is a potential that the pressure tubing may detach from the blood sampling system
Distribution
US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1961-2021, Z-1965-2021, Z-1963-2021, Z-1962-2021, Z-1966-2021, Z-1960-2021, Z-1964-2021, Z-1959-2021

Terminated Class II Medical devices

Recall started
27 March 2020
Terminated
27 April 2021
Reason
Sterile catheter kit packaging compromised.
Distribution
US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
Initiated
Voluntary: Firm initiated
Recall number
Z-2007-2020

Terminated Class II Medical devices

Recall started
27 November 2019
Terminated
28 May 2024
Reason
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.
Distribution
U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. O.U.S. (Foreign): Brazil, Colombia, Albania, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Czech Republic, Denm
Initiated
Voluntary: Firm initiated
Recall number
Z-0800-2020

Terminated Class II Medical devices

Recall started
22 October 2019
Terminated
29 June 2022
Reason
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minne
Initiated
Voluntary: Firm initiated
Recall number
Z-0420-2020

Terminated Class II Medical devices

Recall started
7 October 2019
Terminated
27 April 2021
Reason
Intermittent communication due to inconsistent crimping of connectors onto cables.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.
Initiated
Voluntary: Firm initiated
Recall number
Z-1928-2020

Terminated Class I Medical devices

Recall started
9 July 2019
Terminated
15 September 2020
Reason
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
Distribution
US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2227-2019, Z-2225-2019, Z-2226-2019, Z-2224-2019

Terminated Class I Medical devices

Recall started
14 May 2019
Terminated
23 April 2024
Reason
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.
Distribution
Worldwide Distribution: US (nationwide) to states of: UT, GA, NJ, CA, OH, PA, AL, FL, TN, TX, ME, MA, IN, MS, NY, VA, MI, IL, CO, OR, WA, SC, AZ, SD, MO, CT, OK, NV, WV, WI, NC, MN, KY; and countries of: United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic
Initiated
Voluntary: Firm initiated
Recall number
Z-1705-2019

Terminated Class I Medical devices

Recall started
28 March 2019
Terminated
1 November 2023
Reason
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Distribution
Worldwide Distribution - US Nationwide in the states of : IA, FL, MD, CA, NY, TX, CT, NC, OR, LA, UT,AK, WA, AZ, SD,CO,IN, KY, WV, TN, MI, AL, MA, VA, PA, MO, IL, GA, PR, MN, AR, OK, WI. Foreign (OUS): CL, AR, CZ, SG, BR, ID, ES, IE, GB, AT, CA, AM, HK, AU, ZA, FI, KR, MY, TH, NL, FR, IT, GR, DK,
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1117-2019, Z-1116-2019

Terminated Class I Medical devices

Recall started
21 March 2019
Terminated
28 November 2023
Reason
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
Distribution
Worldwide Distribution - US Nationwide : FL, MD, NY, TX, VA, CO, OK, MO, CA, DE, TN, NC, DC, PA, MA, OR, SC, OH, WI, KS, NV, MI, IL, KY, GA, NJ, WA, CT, IN, MN, WV, LA, MS, AL, SD, NE, IA, AZ, ID, HI, UT, ME,MT, NM, AK, NH, RI, AR, ND, WY, PR. Foreign (OUS): IT, FI, CO, KR, JP, PL, BE, GR, NL,
Initiated
Voluntary: Firm initiated
Recall number
Z-1193-2019

Terminated Class II Medical devices

Recall started
22 January 2019
Terminated
26 March 2019
Reason
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
Distribution
WorldwideDistribution
Initiated
Voluntary: Firm initiated
Recall number
Z-0835-2019

Ongoing Class II Medical devices

Recall started
16 January 2019
Reason
Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
Distribution
Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, France Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, UAE, and United Kingdom.
Initiated
Voluntary: Firm initiated
Recall number
Z-1100-2019

Terminated Class I Medical devices

Recall started
21 December 2018
Terminated
2 November 2023
Reason
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
Distribution
Worldwide Distribution
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0763-2019, Z-0765-2019, Z-0762-2019, Z-0764-2019

Terminated Class II Medical devices

Recall started
11 June 2018
Terminated
23 May 2019
Reason
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Distribution
NJ
Initiated
Voluntary: Firm initiated
Recall number
Z-2435-2018

Terminated Class II Medical devices

Recall started
30 March 2018
Terminated
29 November 2023
Reason
Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
Distribution
Worldwide Distribution -- USA, to the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MS, MO, NV, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV; and, the countries of to Australia, Austria, Belgium, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Luxembou
Initiated
Voluntary: Firm initiated
Recall number
Z-1929-2018

Terminated Class II Medical devices

Recall started
2 October 2017
Terminated
14 December 2020
Reason
Pre-procedural issues related to software defects
Distribution
US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX
Initiated
Voluntary: Firm initiated
Recall number
Z-0496-2018

Terminated Class I Medical devices

Recall started
21 July 2017
Terminated
13 September 2019
Reason
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Distribution
United States: All states with the exception of: Alaska, Hawaii, Idaho, New Mexico, Rhode Island, South Dakota and Wyoming
Initiated
Voluntary: Firm initiated
Recall number
Z-0293-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.