The Recall Desk

Manufacturer

Thoratec Corp.

12 recalls in our database name Thoratec Corp. as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
1
Severe
6
Most recent
2024-06-19

Of the 12 recalls from Thoratec Corp. we have scored against our rubric, 1 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • SevereFDA (Devices)·Z-1921-2024·2024-06-19

    Thoratec HeartMate System Monitor display malfunction in left ventricular assist devices

    The Thoratec HeartMate System Monitor is being recalled due to display malfunctions affecting 4,842 devices worldwide. These issues may prevent proper monitoring and device control.

    Product
    Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1692-2024·2024-05-08

    Left ventricular assist system implant kit recalled for potential inflow cannula seal leak

    Thoratec HeartMate 3 left ventricular assist system implant kits may develop a leak at the seal interface between the inflow cannula and titanium apical cuff, potentially compromising device function.

    Product
    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1693-2024·2024-05-08

    Thoratec HeartMate 3 Left Ventricle Assist System Recalled for Seal Leak

    Thoratec recalls HeartMate 3 left ventricle assist systems due to potential leaks at the seal interface. The FDA Class I recall affects 659 implanted devices worldwide.

    Product
    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1301-2024·2024-03-27

    HeartMate 3 Left Ventricular Assist System recalled for outflow graft obstruction

    The FDA is recalling the HeartMate 3 Left Ventricular Assist System due to observed outflow graft deformation that can obstruct blood flow. Patients with implanted devices should contact their healthcare provider.

    Product
    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1300-2024·2024-03-27

    FDA Recalls HeartMate II Left Ventricular Assist Systems for Graft Obstruction

    Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.

    Product
    HeartMate 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 As
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2024·2024-02-14

    HeartMate Touch Communication System recalled for software pump operation defects

    Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.

    Product
    1. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2658-2023·2023-10-11

    HeartMate Left Ventricular Assist Device Coring Knife Sharpness Defect

    The Apical Coring Knife in HeartMate 3 Left Ventricular Assist System kits may be inadequately sharp, potentially extending surgical implantation time. Thoratec has distributed 2,681 affected units worldwide.

    Product
    Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2022·2021-12-08

    Abbott HeartMate Touch System App may fail due to Bluetooth interference issue

    The Abbott HeartMate Touch Communication System may experience temporary app failure when nearby Bluetooth devices attempt connections. Once properly connected, the system functions normally.

    Product
    Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0746-2020·2020-01-08

    Thoratec HeartMate 3 Mobile Power Unit Recalled for Static Electricity Risk

    Thoratec Corp. is recalling HeartMate 3 Mobile Power Units because excessive static electricity can cause unrecoverable power loss, potentially reducing blood flow from the left ventricular assist system.

    Product
    HeartMate 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: P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2019·2019-08-28

    Thoratec Heartmate 3 Sealed Outflow Graft Recall for Leak Risk

    Thoratec Corp. is recalling 149 Heartmate 3 Sealed Outflow Graft units because the C-Ring may not seat properly, causing leaks during implantation.

    Product
    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2019·2019-08-28

    Thoratec HeartMate 3 LVAS Implant Kit Recalled for Outflow Graft Leaks

    Thoratec Corp. is recalling HeartMate 3 LVAS Implant Kits because an insufficiently seated C-Ring can cause the outflow graft to leak during implantation, rendering the device nonfunctional.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2019·2019-05-01

    Thoratec HeartMate 3 Coring Tool Recalled for Foreign Particle Contamination

    Thoratec Corp. is recalling HeartMate 3 Coring Tools because a small black plastic particle was observed in a patient's left ventricle during an implant procedure.

    Product
    Thoratec 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 Cori
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Thoratec

American medical device manufacturer

Country
United States
Founded
1976

Official website

Source: Wikidata (Q7796156), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.