Device recall
Z-1557-2010: VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular…
FDA device recall · Class II · Boston Scientific CRM Corp
Key facts
| Recall number (Z-number) | Z-1557-2010 |
|---|---|
| Recall event | 55216 |
| Product | VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. AVT, model A155. VITALITY DS DR/VR (Models T125, T135), VITALITY 2 DR/VR (Models T165, T175) and VITALITY 2 EL DR/VR (Models T167, T177) Implantable Cardioverter Defibrillator. Guidant Corporation Cardiac Rhythm… |
| Product code | KRG |
| Recalling firm | Boston Scientific CRM Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 5, 2012 |
| PMA numbers | P960040, P960040S031 |
| 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