Device recall
Z-1531-2021: ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm…
FDA device recall · Class I · St. Jude Medical, Cardian Rhythm Management Division
Key facts
| Recall number (Z-number) | Z-1531-2021 |
|---|---|
| Recall event | 87558 |
| Product | ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing. |
| Product code | NVZ |
| Recalling firm | St. Jude Medical, Cardian Rhythm Management Division |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P140033, P880086, P880086S230 |
| FEI number | 2017865 |
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