Heart & Vascular Devices recalls

6,227 medical device recalls in the heart & vascular devices category are on file with the FDA, from 2012 to 21 Oct 2026.

Total recalls6,227since 2012

Last 12 months416reported

Class I91615% of total

Ongoing1,785latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

19Nov '24 11 13 22Feb 27 21 23May 15 20 10Aug 28 42 19Nov 14 6 56Feb 5 69 59May 49 71 18Aug 35 15

Severity split

Class I 916 15%Class II 5,254 84%Class III 57 1%

Why heart & vascular devices is recalled

Companies

Brands

sold under10%
Stryker10%

By year

20263836%
20252544%
20244617%
20232374%
20222364%
20213746%
202066411%
20195499%
20185839%
20172895%

Ongoing heart & vascular devices recalls

1,785 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	NaviFlex LW Pusher recalled by Boston Scientific	Boston Scientific	Other	Nationwide
21 Oct 2026Device	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide
21 Oct 2026Device	CLASS II	Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recalled	Sarnova HC	Other	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide
21 Oct 2026Device	CLASS II	The Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide

All heart & vascular devices recalls, newest first

6,227 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	NaviFlex LW Pusher recalled by Boston Scientific	Boston Scientific	Other	Nationwide
21 Oct 2026Device	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide
21 Oct 2026Device	CLASS II	Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recalled	Sarnova HC	Other	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide
21 Oct 2026Device	CLASS II	The Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
21 Oct 2026Device	CLASS II	JenaValve Trilogy Delivery Catheter, Size recalled	Jenavalve Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	System (RED 62 Reperfusion Catheter) recalled by Penumbra	Penumbra	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS I	Imager II Angiographic Catheters M001314001 Imager recalled	Boston Scientific	Other	Nationwide
30 Sep 2026Device	CLASS II	Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled	Olympus Corporation of the Americas	Other	PA
30 Sep 2026Device	CLASS II	Cardioroot Woven Collagen Coated Vascular Graft recalled	SAS Intervascular	Other	Nationwide
30 Sep 2026Device	CLASS II	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS I	DuoGlide Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states
23 Sep 2026Device	CLASS II	EWO_02513 (Catalog number 320122) For Investigational Use Only Nano recalled	embecta Medical II	Other	Nationwide
23 Sep 2026Device	CLASS II	EWO_02512 (Catalog number 320550) For Investigational Use Only Nano recalled	embecta Medical II	Other	Nationwide
23 Sep 2026Device	CLASS I	Power-Trialysis Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller, Automated Impella Controller recalled	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller with the below product recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide

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.