Device recall
Z-0891-06: CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization…
FDA device recall · Class III · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0891-06 |
|---|---|
| Recall event | 33716 |
| Product | CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 devices provide ventricular… |
| Product code | NIK |
| Recalling firm | Guidant Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 16, 2007 |
| 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