Recall Register

Food, drugs, devices › Firms

Thoratec Corp.

FDA recalling firm · 9 enforcement events · 12 product records · 2019–2024 · CA

Thoratec Corp. has 9 FDA enforcement events on this register (12 product records) between 2019 and 2024: 9 device; the busiest year was 2024 with 4.

44% of its events are Class I; the most common class is Class II (5). 6 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
8 May 2024Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist deviceDeviceClass I1Ongoing
1 Mar 2024Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnlyDeviceClass I2Ongoing
19 Feb 2024HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS…DeviceClass I2Ongoing
3 Jan 20241. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting…DeviceClass I1Ongoing
7 Aug 2023Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050DeviceClass II1Ongoing
22 Oct 2021Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)DeviceClass II1Ongoing
2 Dec 2019HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller…DeviceClass II1Terminated
30 Mar 2019Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist SystemDeviceClass II2Terminated
1 Mar 2019Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a…DeviceClass II1Terminated

By type and class

Device9
Class II5
Class I4

Class I: 44% of this firm's events; 18% of all events on the register.

Events by year

19
20
21
22
23
24
25
26
Enforcement events for Thoratec Corp. by year initiated.

Questions and answers

How many FDA recalls has Thoratec Corp. had?

9 enforcement events (12 product records) on this register, 2019–2024: 9 device.

Are any Thoratec Corp. recalls ongoing?

6 events are listed as ongoing in the current openFDA export.

What class are Thoratec Corp. recalls?

5 Class II, 4 Class I. 44% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.