Drug recall
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF…
FDA recall event 93697 · Class I · Thoratec Corp.
Key facts
| Event ID | 93697 |
|---|---|
| Recall numbers | Z-0842-2024 |
| Recalling firm | Thoratec Corp. |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to software and controller systems that results in unexpected pump start or pump stop. |
| Initiation date | Jan 3, 2024 |
| Report date | Feb 14, 2024 |
| City | Pleasanton |
| State | CA |
| Country | United States |
| FEI number | 2916596 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: