Device recall
Z-0953-05: CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model…
FDA device recall · Class II · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0953-05 |
|---|---|
| Recall event | 32496 |
| Product | CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac Resynchronization Therapy Defibrillator. Sterile EO. Guidant Corporation, 4100 Hamiline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 RF devices provide ventricular tachyarrhythmia and… |
| Product code | NIK |
| Recalling firm | Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 31, 2006 |
| 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