Device recall
Z-0038-2018: PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices…
FDA device recall · Class II · St Jude Medical Inc.
Key facts
| Recall number (Z-number) | Z-0038-2018 |
|---|---|
| Recall event | 78093 |
| Product | PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These… |
| 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