Device recall
Z-1559-2010: VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model…
FDA device recall · Class II · Boston Scientific CRM Corp
Key facts
| Recall number (Z-number) | Z-1559-2010 |
|---|---|
| Recall event | 55216 |
| Product | VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR HE, model 1853 and 1858, PRIZM VR HE, model 1857, PRIZM 2 VR model 1860 and PRIZM 2 DR model 1861. The ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and… |
| Product code | LWP |
| Recalling firm | Boston Scientific CRM Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 5, 2012 |
| PMA numbers | P960040, P960040S012 |
| 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