Device recall
Z-0842-2024: 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch…
FDA device recall · Class I · Thoratec Corp.
Key facts
| Recall number (Z-number) | Z-0842-2024 |
|---|---|
| Recall event | 93697 |
| 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… |
| Product code | DSQ |
| Recalling firm | Thoratec Corp. |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P160054 |
| FEI number | 2916596 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database