Edwards Lifesciences recalls

Edwards Lifesciences has 95 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 20 May 2026. 22 are still ongoing. 1 was reported in the last 12 months.

Total recalls95since 2012

Last 12 months1reported

Class I2021% of total

Ongoing22latest 20 May 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 6 0Aug 0 0 0Nov 0 0 0Feb 0 0 1May 0 0 0Aug 0 0

Severity split

Class I 20 21%Class II 74 78%Class III 1 1%

Why edwards lifesciences is recalled

Product types

By year

202611%
202566%
20231011%
202244%
20211415%
202033%
20191516%
201844%
201711%
201577%

Ongoing edwards lifesciences recalls

22 active

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	Edwards Evoque tricuspid delivery system recalled	Edwards Lifesciences	Other	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide

All edwards lifesciences recalls, newest first

95 total

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	Edwards Evoque tricuspid delivery system recalled	Edwards Lifesciences	Other	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
6 Dec 2023Device	CLASS II	Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5 recalled	Edwards Lifesciences	Device Malfunction	43 states
6 Dec 2023Device	CLASS II	FloTrac Sensor with Vamp System recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	43 states
6 Dec 2023Device	CLASS II	TruWave with Vamp System Pressure monitoring set recalled	Edwards Lifesciences	Other	43 states
6 Dec 2023Device	CLASS II	FloTrac Sensor recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	43 states
6 Dec 2023Device	CLASS II	TruWave Pressure monitoring set recalled by Edwards Lifesciences	Edwards Lifesciences	Other	43 states
6 Dec 2023Device	CLASS II	Acumen IQ Sensor with Vamp System, REFs: AIQS6AZ & AIQS6AZ5 recalled	Edwards Lifesciences	Device Malfunction	43 states
15 Nov 2023Device	CLASS II	Fogarty Thru-Lumen Embolectomy Catheter recalled by Edwards Lifesciences	Edwards Lifesciences	Other	CA
6 Sep 2023Device	CLASS II	Pascal Precision Transcatheter Valve Repair System recalled	Edwards Lifesciences	Other	CA
19 Apr 2023Device	CLASS II	Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V recalled	Edwards Lifesciences	Other	42 states
19 Apr 2023Device	CLASS II	Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V recalled	Edwards Lifesciences	Other	42 states
9 Nov 2022Device	CLASS II	Fogarty Biliary Balloon Probes recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	Nationwide
9 Nov 2022Device	CLASS II	Fogarty Arterial Embolectomy Catheters recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	Nationwide
6 Apr 2022Device	CLASS II	Fore-sight Elite Tissue Oximeter module recalled by Edwards Lifesciences	Edwards Lifesciences	Labeling Errors	Nationwide
6 Apr 2022Device	CLASS II	Fore-sight Elite Absolute Tissue Oximeter recalled	Edwards Lifesciences	Labeling Errors	Nationwide
18 Aug 2021Device	CLASS II	Edwards PediaSat Oximetry Catheter Kit recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021Device	CLASS II	Edwards PediaSat Oximetry Catheter Set recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021Device	CLASS II	Edwards PediaSat Oximetry Catheter Kit recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021Device	CLASS II	Edwards PediaSat Oximetry Catheter Kit recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021Device	CLASS II	Edwards PediaSat Oximetry Catheter Set recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
18 Aug 2021Device	CLASS II	Edwards PediaSat Oximetry Catheter Set recalled by Edwards Lifesciences	Edwards Lifesciences	Packaging Defects	12 states
7 Jul 2021Device	CLASS II	Edwards TruWave (3 cc)/VAMP Jr Kit recalled by Edwards Lifesciences	Edwards Lifesciences	Other	29 states
7 Jul 2021Device	CLASS II	Edwards TruWave (30 cc)/VAMP Jr Kit recalled by Edwards Lifesciences	Edwards Lifesciences	Other	29 states
7 Jul 2021Device	CLASS II	Edwards TruWave (30 cc)/VAMP Jr/ Kit recalled by Edwards Lifesciences	Edwards Lifesciences	Other	29 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.