Device recall
Z-0906-05: Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator…
FDA device recall · Class I · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0906-05 |
|---|---|
| Recall event | 32379 |
| Product | Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and… |
| Product code | KRG |
| Recalling firm | Guidant Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 5, 2007 |
| PMA numbers | P960040, P960040S015 |
| FEI number | 2124215 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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