FDA recall record · openFDA

Edwards Lifesciences, LLC

17 FDA recalls on record (2023–2026) — 17 device. 17 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. 6

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. 6

There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to 2

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 s 1

Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid v 1

Recalls

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V Class I 2025-05-14 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Class I 2025-05-14 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Class I 2025-05-14 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Class I 2025-05-14 Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Class I 2025-05-14 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software V Class I 2025-05-14 Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO Class II 2026-03-27 Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 Class II 2023-09-07 Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F Class II 2023-02-14 PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS Class II 2023-07-27 Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monit Class II 2023-10-04 TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284 Class II 2023-10-04 FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure mo Class II 2023-10-04 TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK036 Class II 2023-10-04 Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2. Class II 2023-02-14 FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure mo Class II 2023-10-04 Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravas Class II 2023-10-04

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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