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HeartMate Touch™ HMT2100

by Thoratec Corporation

Ref HMT2100

HeartMate Touch™ HMT2100 is a device classified as Active implantable (AIMDD) (EU), Class III (US) made by Thoratec Corporation, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-05415067032065), approved under FDA PMA P160054 on 23 Aug 2017 (1 earlier submission) and listed in FDA GUDID since 4 May 2020 (UDI-DI 05415067032065), active as of 7 Nov 2026. 32 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE AIMDD PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

17 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

PMA P160054

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-05415067032065 Basic UDI-DI 05415067032065UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067032065 UDI-DI Date4 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP160054 Date23 Aug 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05415067032065 registered 6 Nov 2026 Active
  • FDA PMA P160054 decided 23 Aug 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05415067032065 listed 4 May 2020 Listed

Recalls

32 recalls · 17 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.

  • 4 recalls, same reason

    • Ongoing Z-0507-2026 FDA Class II initiated 9 Oct 2025
    • Ongoing Z-0506-2026 FDA Class II initiated 9 Oct 2025
    • Ongoing Z-0508-2026 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-2291-2025 FDA Class I initiated 23 Jun 2025
    • Ongoing Z-2290-2025 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.

  • 2 recalls, same reason

    • Ongoing Z-1300-2024 FDA Class I initiated 19 Feb 2024
    • 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-2348-2019 FDA Class II initiated 30 Mar 2019
    • Terminated Z-2349-2019 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.

  • 3 recalls, same reason

    • Terminated Z-2052-2017 FDA Class I initiated 30 Mar 2017
    • Terminated Z-2051-2017 FDA Class I initiated 30 Mar 2017
    • Terminated Z-2053-2017 FDA Class I initiated 30 Mar 2017

    St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

  • 4 recalls, same reason

    • Terminated Z-1228-2014 FDA Class I initiated 4 Mar 2014
    • Terminated Z-1230-2014 FDA Class I initiated 4 Mar 2014
    • Terminated Z-1227-2014 FDA Class I initiated 4 Mar 2014
    • Terminated Z-229-2014 FDA Class I initiated 4 Mar 2014

    Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

    • Terminated Z-1228-2012 FDA Not yet classified initiated 23 Feb 2012

    A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified

    • Terminated Z-0058-2011 FDA Unclassified (pre-2012) initiated 1 Sep 2010

    Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection

    • Terminated Z-0422-2010 FDA Unclassified (pre-2012) initiated 14 Oct 2009

    Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled

    • Terminated Z-0496-2009 FDA Unclassified (pre-2012) initiated 24 Oct 2008

    The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with external system controller may result in damage that has the potential to interrupt pump function and may require a reoperation to replace the pump.

Timeline

36 dated events

  1. Recall initiated FDA recalls Z-2291-2025
  2. Recall initiated FDA recalls Z-2290-2025
  3. Recall initiated FDA recalls Z-0507-2026
  4. Recall initiated FDA recalls Z-0506-2026
  5. Recall initiated FDA recalls Z-0508-2026
  6. Recall initiated FDA recalls Z-0505-2026
  7. Recall initiated FDA recalls Z-2519-2026
  8. Recall initiated FDA recalls Z-2518-2026
  9. Recall initiated FDA recalls Z-2520-2026
  10. Registered EUDAMED B-05415067032065

26 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/AIMDD Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
HeartMate™ Touch™ EUDAMED
HeartMate Touch™ GUDID
Generic name
Medical networking interface unit
Device name
HeartMate Wireless Adapter
Model / Ref / Catalog
HMT2100
Primary DI / UDI-DI
05415067032065
Basic UDI-DI
B-05415067032065
PMA number
FDA product code
DSQ
EMDN code
J010380 Implantable ventricular assistance systems - accessories
GMDN term
Medical networking interface unit
Device class
Class AIMDD EUDAMED
Class III GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class AIMDD
GUDID
Class III

Device class is stated on each registry's own scale: Class AIMDD in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Medical networking interface unit

Cleared under the same submission (P060040)

and 7 more cleared under P060040

Cleared under the same submission (P160054)

and 8 more cleared under P160054

Similar devices in this category

Other devices filed under CARDIAC FUNCTIONALITY IMPLANTABLE DEVICES.

Other devices from Thoratec Corporation

See all devices from Thoratec Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)