Device recall
Z-0029-2018: Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222…
FDA device recall · Class II · St Jude Medical Inc.
Key facts
| Recall number (Z-number) | Z-0029-2018 |
|---|---|
| Recall event | 78093 |
| Product | Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue… |
| Product code | NKE |
| Recalling firm | St Jude Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2020 |
| PMA numbers | P030035, P030035S157 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 10–99 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