Device recall
Z-0194-05: Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model…
FDA device recall · Class II · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0194-05 |
|---|---|
| Recall event | 33871 |
| Product | Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable… |
| Product code | DXY |
| Recalling firm | Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2007 |
| 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