Device recall
Z-1194-06: Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE…
FDA device recall · Class II · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1194-06 |
|---|---|
| Recall event | 35537 |
| Product | Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL 4 AVT (models M170, M175), CONTAK RENEWAL 4 AVT HE (models M177, M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac… |
| Product code | LWP |
| Recalling firm | Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 6, 2007 |
| 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