Device recall
Z-0342-2016: Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator…
FDA device recall · Class II · Medtronic Inc.
Key facts
| Recall number (Z-number) | Z-0342-2016 |
|---|---|
| Recall event | 72618 |
| Product | Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker. |
| Product code | NKE |
| Recalling firm | Medtronic Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2016 |
| PMA numbers | P010015 |
| FEI number | 2182208 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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