Device recall
Z-1351-2020: Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC…
FDA device recall · Class II · St Jude Medical, Cardiac Rhythm Management Division
Key facts
| Recall number (Z-number) | Z-1351-2020 |
|---|---|
| Recall event | 84849 |
| Product | Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330 |
| Product code | NVZ |
| Recalling firm | St Jude Medical, Cardiac Rhythm Management Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2020 |
| PMA numbers | P910023, P910023S309 |
| 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