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HeartMate 3™ 10005872

by Thoratec Corporation

HeartMate 3™ 10005872 is a Class III device made by Thoratec Corporation, approved under FDA PMA P160054 on 23 Aug 2017 and listed in FDA GUDID since 14 Jun 2022 (UDI-DI 05415067038760), active as of 23 Oct 2026. 18 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

14 ongoing

This device is named in the recall

Documents

PMA P160054

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05415067038760 UDI-DI Date14 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP160054 Date23 Aug 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P160054 decided 23 Aug 2017 Active
  • FDA GUDID UDI-DI 05415067038760 listed 14 Jun 2022 Listed

Recalls

18 recalls · 14 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2519-2026 FDA Class II initiated 13 May 2026
    • Ongoing Z-2518-2026 FDA Class II initiated 13 May 2026
    • Ongoing Z-2520-2026 FDA Class II initiated 13 May 2026

    Due to 11 volt Backup Battery failures.

  • 2 recalls, same reason

    • Ongoing Z-0506-2026 FDA Class II initiated 9 Oct 2025
    • Ongoing Z-0505-2026 FDA Class II initiated 9 Oct 2025

    Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

  • 2 recalls, same reason

    • Ongoing Z-2290-2025 FDA Class I initiated 23 Jun 2025
    • Ongoing Z-2291-2025 FDA Class I initiated 23 Jun 2025

    Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.

    • Ongoing Z-1570-2025 FDA Class I initiated 13 Mar 2025

    Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.

    • Ongoing Z-2583-2024 FDA Class II initiated 25 Jun 2024

    Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

    • Ongoing Z-1921-2024 FDA Class I initiated 8 May 2024

    System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

  • 2 recalls, same reason

    • Ongoing Z-1693-2024 FDA Class I initiated 1 Mar 2024
    • Ongoing Z-1692-2024 FDA Class I initiated 1 Mar 2024

    Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

    • Ongoing Z-1301-2024 FDA Class I initiated 19 Feb 2024

    Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

    • Ongoing Z-0842-2024 FDA Class I initiated 3 Jan 2024

    Due to software and controller systems that results in unexpected pump start or pump stop.

    • Terminated Z-0746-2020 FDA Class II initiated 2 Dec 2019

    Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.

  • 2 recalls, same reason

    • Terminated Z-2349-2019 FDA Class II initiated 30 Mar 2019
    • Terminated Z-2348-2019 FDA Class II initiated 30 Mar 2019

    Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

    • Terminated Z-1774-2018 FDA Class I initiated 5 Apr 2018

    Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.

Timeline

20 dated events

  1. Recall initiated FDA recalls Z-1921-2024
  2. Recall initiated FDA recalls Z-2583-2024
  3. Recall initiated FDA recalls Z-1570-2025
  4. Recall initiated FDA recalls Z-2290-2025
  5. Recall initiated FDA recalls Z-2291-2025
  6. Recall initiated FDA recalls Z-0506-2026
  7. Recall initiated FDA recalls Z-0505-2026
  8. Recall initiated FDA recalls Z-2519-2026
  9. Recall initiated FDA recalls Z-2518-2026
  10. Recall initiated FDA recalls Z-2520-2026

10 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
HeartMate 3™
Generic name
Cardiothoracic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
10005872
Primary DI / UDI-DI
05415067038760
PMA number
FDA product code
DSQ
GMDN term
Cardiothoracic surgical procedure kit, non-medicated, single-use
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiothoracic surgical procedure kit, non-medicated, single-use

Cleared under the same submission (P160054)

and 8 more cleared under P160054

Similar devices

Other devices filed under FDA product code DSQ (Ventricular (assist) bypass).

Other devices from Thoratec Corporation

See all devices from Thoratec Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)