1 — Class I medical device recall Z-0842-2024
Ongoing recall by Thoratec Corp., reported 2024-02-14, distributed nationwide. Due to software and controller systems that results in unexpected pump start or pump stop.
| Recall number | Z-0842-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2024-01-03 |
| Classified | 2024-02-02 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, CO, CZ, DE, ES, HK, IL, IT, JO, KR, KW, LB, NZ, PL, RO, SA, SG, TH |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05415067032041, 05415067032058, 05415067033758 |
| Serial numbers | DMPV40AAHP83, DMPVJAYAHP51, DMPVN1DFHP83, DMPVQ2JSHP51, DMPVQ374HP51, DMPVR6EXHP51, DMPVW1KDHP51, DMPW90USHP83, DMPWD118HP83, DMPWG096HP83, DMPWH036HP83, DMPWL02KHP83, DMPWL04QHP83, DMPWL05PHP83, DMPWL0AMHP83, DMPWL0T1HP83, DMPWL0XHHP83, DMPWL0Y3HP83, DMPWL111HP83, DMPWL13CHP83, DMPWL14XHP83, DMPWL19RHP83, DMPWL1A2HP83, DMPWL1B7HP83, DMPWL1BPHP83 and 475 more |
| Model numbers | HMT1100, HMT1100-R, HMT1150 |
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 for recall
Due to software and controller systems that results in unexpected pump start or pump stop.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0842-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.