Device recall
Z-1932-2009: Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator…
FDA device recall · Class II · Boston Scientific CRM Corp
Key facts
| Recall number (Z-number) | Z-1932-2009 |
|---|---|
| Recall event | 52809 |
| Product | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to… |
| Product code | LWP |
| Recalling firm | Boston Scientific CRM Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2012 |
| PMA numbers | P010012, P010012S165, P960040, P960040S155 |
| 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