Thoratec recalls

Thoratec has 29 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 24 Jun 2026. 19 are still ongoing. 8 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls29since 2014

Last 12 months8reported

Class I1448% of total

Ongoing19latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 2Aug 0 0 4Nov 0 1 0Feb 0 0 0May 3 0 0Aug 0 0

Severity split

Class I 14 48%Class II 15 52%Class III 0 0%

Why thoratec is recalled

Product types

By year

2026414%
2025724%
2024621%
202313%
202113%
202013%
2019310%
201727%
2014414%

Ongoing thoratec recalls

19 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	HeartMate HM 11V Li-ion Backup Battery, ABT recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	HeartMate 3" System Controller recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	CentriMag Blood Pump recalled by Thoratec	Thoratec	Particulate Matter	Nationwide
26 Nov 2025Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	HeartMate II¿ LVAS Implant Kit recalled by Thoratec	Thoratec	Device Malfunction	Nationwide

All thoratec recalls, newest first

29 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	HeartMate HM 11V Li-ion Backup Battery, ABT recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	HeartMate 3" System Controller recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	CentriMag Blood Pump recalled by Thoratec	Thoratec	Particulate Matter	Nationwide
26 Nov 2025Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	HeartMate II¿ LVAS Implant Kit recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	HeartMate II¿ Controller (standalone) recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	HeartMate 3 Controller (Standalone) recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
20 Aug 2025Device	CLASS I	HeartMate Mobile Power Unit recalled by Thoratec	Thoratec	Packaging Defects	Nationwide
20 Aug 2025Device	CLASS I	HeartMate Mobile Power Unit, AC Power Cord recalled by Thoratec	Thoratec	Packaging Defects	Nationwide
23 Apr 2025Device	CLASS I	HeartMate Mobile Power Unit recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
21 Aug 2024Device	CLASS II	HeartMate 3 System Controllers provided within recalled by Thoratec	Thoratec	Device Malfunction	42 states
19 Jun 2024Device	CLASS I	HeartMate System Monitor recalled by Thoratec	Thoratec	Other	Nationwide
8 May 2024Device	CLASS I	HeartMate 3, LVAS Implant Kit recalled by Thoratec	Thoratec	Packaging Defects	Nationwide
8 May 2024Device	CLASS I	HeartMate 3, LVAS Implant Kit recalled by Thoratec	Thoratec	Packaging Defects	Nationwide
27 Mar 2024Device	CLASS I	HeartMate II Left Ventricular Assist System (LVAS) recalled by Thoratec	Thoratec	Packaging Defects	Nationwide
14 Feb 2024Device	CLASS I	HeartMate Touch Communication System recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
11 Oct 2023Device	CLASS II	Heartmate 3 LVAS Implant Kit recalled by Thoratec	Thoratec	Other	Nationwide
8 Dec 2021Device	CLASS II	Abbott HeartMate Touch Communication System recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
8 Jan 2020Device	CLASS II	HeartMate 3 Mobile Power Unit recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
28 Aug 2019Device	CLASS II	HeartMate 3 LVAS Implant Kit, Sterile recalled by Thoratec	Thoratec	Packaging Defects	Nationwide
28 Aug 2019Device	CLASS II	Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile recalled	Thoratec	Packaging Defects	Nationwide
1 May 2019Device	CLASS II	HeartMate 3 Coring Tool, Sterile EO recalled by Thoratec	Thoratec	Foreign Material	Nationwide
31 May 2017Device	CLASS I	HeartMate¿ II LVAS with Pocket Controller recalled by Thoratec	Thoratec	Device Malfunction	CA
31 May 2017Device	CLASS I	HeartMate¿ II LVAS with Pocket Controller recalled by Thoratec	Thoratec	Device Malfunction	CA
2 Apr 2014Device	CLASS I	HeartMate II Implant Kit with Pocket Controller recalled by Thoratec	Thoratec	Packaging Defects	Nationwide
2 Apr 2014Device	CLASS I	Heart Mate II Pocket Controllers removed from packaging recalled	Thoratec	Packaging Defects	Nationwide
2 Apr 2014Device	CLASS I	HeartMate II LVAD Pump and Pock Controller Kit recalled by Thoratec	Thoratec	Other	Nationwide
2 Apr 2014Device	CLASS I	HeartMate II System Controller recalled by Thoratec	Thoratec	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.