Device recall
Z-0907-05: CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization…
FDA device recall · Class I · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0907-05 |
|---|---|
| Recall event | 32380 |
| Product | CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798. USA. Renewal provides ventricular tachyarrhythmia… |
| Product code | NIK |
| Recalling firm | Guidant Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 10, 2007 |
| PMA numbers | P010012, P010012S002 |
| 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