FDA Device recall Z-0842-2024
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Commu…
- FDA Device
- Class I
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class I recall of 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Commu… by Thoratec, citing due to software and controller systems that results in unexpected pump start or pump stop.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0842-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-01-03 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Thoratec |
| Distribution | US |
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 hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.
Reason
Due to software and controller systems that results in unexpected pump start or pump stop.
Identifiers
| code_info | HeartMate Touch Communication System Model Number: HMT1100 UDI-DI Code: 05415067032058 Serial Numbers: DMPV40AAHP83 DMP…HeartMate Touch Communication System Model Number: HMT1100 UDI-DI Code: 05415067032058 Serial Numbers: DMPV40AAHP83 DMPVN1DFHP83 DMPVQ2JSHP51 DMPVQ374HP51 DMPVR6EXHP51 DMPVW1KDHP51 DMPW90USHP83 DMPWD118HP83 DMPWG096HP83 DMPWH036HP83 DMPWL02KHP83 DMPWL04QHP83 DMPWL05PHP83 DMPWL0AMHP83 DMPWL0T1HP83 DMPWL0XHHP83 DMPWL111HP83 DMPWL13CHP83 DMPWL14XHP83 DMPWL19RHP83 DMPWL1B7HP83 DMPWL1BPHP83 DMPWL1CCHP83 DMPWL1DVHP83 DMPWL21LHP83 DMPWL243HP83 DMPWL24PHP83 DMPWL29YHP83 DMPWL2BAHP83 DMPWL2DAHP83 DMPWM02VHP83 DMPWM0B5HP83 DMPWN01MHP83 DMPWN041HP83 DMPWN0A0HP83 DMPWN0AVHP83 DMPWN0XRJ28L DMPWR0AKHP83 DMPWR0AZHP83 DMPWR0BSHP83 DMPWR0C5HP83 DMPWR0CCHP83 DMPWR0DWHP83 DMPWR10BHP83 DMPWR11AHP83 DMPWR124HP83 DMPWR160HP83 DMPWR16ZHP83 DMPWR17CHP83 DMPWR17SHP83 DMPWR19BHP83 DMPWR19JHP83 DMPWR1D2HP83 DMPWR1DTHP83 DMPWR1F6HP83 DMPWR1MZHP83 DMPWT00PHP83 DMPWT02RHP83 DMPWT0CBHP83 DMPWT0NQHP83 DMPWT0PJHP83 DMPWT0URHP83 DMPWT0YHHP83 DMPWT118HP83 DMPWV09DHP83 DMPWV0BHHP51 DMPWV0C5HP83 DMPWV0C6HP83 DMPWV0CCHP83 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0842-2024%22
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