Device recall
Z-1465-2021: BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831…
FDA device recall · Class II · BIOTRONIK Inc
Key facts
| Recall number (Z-number) | Z-1465-2021 |
|---|---|
| Recall event | 87549 |
| Product | BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. |
| Product code | LWS |
| Recalling firm | BIOTRONIK Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2023 |
| PMA numbers | P980023, P980023S093 |
| FEI number | 1028232 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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