Device recall
Z-1065-05: CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy…
FDA device recall · Class II · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1065-05 |
|---|---|
| Recall event | 32495 |
| Product | CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. Provides ventricular tachyarrhythmia and… |
| Product code | NIK |
| Recalling firm | Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2005 |
| PMA numbers | P010012, P010012S008 |
| 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