Device recall
Z-1110-2022: Instructions for Use, Patient Manuals, and Emergency Responder Guides for…
FDA device recall · Class II · Medtronic Inc
Key facts
| Recall number (Z-number) | Z-1110-2022 |
|---|---|
| Recall event | 89967 |
| Product | Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique… |
| Product code | DSQ |
| Recalling firm | Medtronic Inc |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P100047 |
| FEI number | 3001504994 |
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