Device recall
Z-0863-06: CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217…
FDA device recall · Class III · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0863-06 |
|---|---|
| Recall event | 34860 |
| Product | CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies… |
| Product code | NIK |
| Recalling firm | Guidant Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 31, 2006 |
| PMA numbers | P010012 |
| FEI number | 2124215 |
At a glance
- None Linked 510(k)s
- 1–9 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