Edwards Lifesciences, LLC: 48 recalls on record

Recalls filed with 1 agency: FDA (48).

First recall on record: July 18, 2012. Most recent: May 20, 2026.

Risk classification: Class I: 10 · Class II: 37 · Class III: 1

Most recent recalls

DateAgencyProduct
May 20, 2026FDAEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EOZ-2172-2026
July 16, 2025FDABrand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Cat…Z-2080-2025
July 16, 2025FDABrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FE…Z-2084-2025
July 16, 2025FDABrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FE…Z-2083-2025
November 15, 2023FDAFogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35Z-0238-2024
July 7, 2021FDAEdwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring S…Z-1961-2021
January 22, 2020FDAQuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182…Z-0800-2020
November 27, 2019FDAEZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector …Z-0420-2020
August 28, 2019FDAEdwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) …Z-2227-2019
June 19, 2019FDAIntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm),…Z-1705-2019
May 1, 2019FDAEdwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF…Z-1116-2019
May 1, 2019FDAEdwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: …Z-1117-2019
February 6, 2019FDAEdwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Pro…Z-0763-2019
February 6, 2019FDAEdwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The …Z-0765-2019
July 25, 2018FDAEdwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mmZ-2435-2018
September 6, 2017FDAFogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fo…Z-3077-2017
December 16, 2015FDAThin-Flex Venous Cannula, Model Number:TF292902AZ-0398-2016
June 10, 2015FDASwan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed…Z-1700-2015
November 26, 2014FDAEdwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, pe…Z-0217-2015
April 23, 2014FDAEdwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arte…Z-1467-2014
April 23, 2014FDAEdwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 1…Z-1466-2014
February 12, 2014FDACrimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIE…Z-0918-2014
January 1, 2014FDAEdwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Mode…Z-0560-2014
November 13, 2013FDAEdwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, R…Z-0135-2014
November 13, 2013FDAEdwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225,…Z-0134-2014

Questions about this company

How many recalls does Edwards Lifesciences, LLC have?
Recalert has 48 U.S. recalls on record for Edwards Lifesciences, LLC, published between July 18, 2012 and May 20, 2026.
What was the most recent Edwards Lifesciences, LLC recall?
FDA recall Z-2172-2026, published May 20, 2026: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Which agencies have handled Edwards Lifesciences, LLC recalls?
Edwards Lifesciences, LLC appears as the recalling firm in recalls from: FDA (48).

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