Thoratec Corp. recalls
Every recall we track for Thoratec Corp. — 12 in all, from 2019–2024 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Thoratec Corp. dropped to zero in 2025 (0, down from 6 in 2024). 8% rated “stop using now”.
All FDA recall records for Thoratec Corp. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 3 | 0 | 1 | 4 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 0 | 0 | 1 |
| 2024 | 1 | 3 | 0 | 2 | 6 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Thoratec Corp. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Thoratec Corp. recalls
9 shown- Use cautionMedical device
Thoratec Corp. recalls Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386,
Thoratec recalls HeartMate System Monitors with specific serial numbers due to screen errors that could cause anxiety, pump issues, or extended surgery time. Affected units may display overlapping buttons, frozen screens, or distorted text.
ThoratecMay 8, 2024 - Use cautionMedical device
Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Thoratec recalls HeartMate 3 LVAS Implant Kit (REF:106524US) due to potential leak path at seal interface. This may cause complications for heart failure patients. Check your serial numbers for affected units.
ThoratecMar 1, 2024 - UnratedMedical device
Thoratec Corp. recalls HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief,
Thoratec recalls HeartMate 3 Left Ventricular Assist Systems with potential Extrinsic Outflow Graft Obstruction (EOGO) that may cause device malfunction. Affected units include specific model numbers and serial ranges.
ThoratecFeb 19, 2024 - Use cautionMedical device
Thoratec Corp. recalls 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3.
Thoratec recalls HeartMate Touch Communication System models HMT1100 and HMT1150 due to software and controller systems causing unexpected pump start or stop. Affected units have specific serial numbers listed in the recall notice.
Thoratec Corp.Jan 3, 2024 - Use cautionMedical device
Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Thoratec recalls Heartmate 3 LVAS Implant Kit and Heartmate XVE/II Apical Coring Knives due to inadequate sharpness causing extended surgery time. Affected units have specific serial numbers.
ThoratecAug 7, 2023 - Lower riskMedical device
Thoratec Corp. recalls Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Abbott HeartMate Touch Communication System (HMT1100, HMT1100-R, HMT1150) may experience app crashes due to Bluetooth interference with nearby devices. No action needed as the device continues to function normally.
ThoratecOct 22, 2021 - Use cautionMedical device
Thoratec Corp. recalls HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when
Thoratec recalls HeartMate 3 Mobile Power Unit models with specific serial numbers due to static electricity causing power loss that may reduce blood flow from the assist system.
ThoratecDec 2, 2019 - Use cautionMedical device
Thoratec Corp. recalls Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left
Thoratec recalls Heartmate 3 Sealed Outflow Graft with Bend Relief for potential leaking during implantation. If the C-Ring isn't seated properly, the device may not function during surgery.
ThoratecMar 30, 2019 - UnratedMedical device
Thoratec Corp. recalls Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left
Thoratec recalls HeartMate 3 Coring Tool (REF 10005872) due to small black plastic particles found in left ventricle during implant. Affected units have specific lot numbers.
ThoratecMar 1, 2019
Thoratec Corp. recall questions
How many recalls has Thoratec Corp. had?
12 recalls from Thoratec Corp. are on record with U.S. safety agencies, from 2019–2024.
What is the most recent Thoratec Corp. recall?
Thoratec Corp. recalls Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386,, dated May 8, 2024. Every Thoratec Corp. recall is listed on this page, newest first.
What should I do if I have a recalled Thoratec Corp. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Thoratec Corp. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.