Device recall
Z-1632-2016: Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q…
FDA device recall · Class II · St Jude Medical Inc.
Key facts
| Recall number (Z-number) | Z-1632-2016 |
|---|---|
| Recall event | 73837 |
| Product | Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. |
| Product code | LWS |
| Recalling firm | St Jude Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2016 |
| PMA numbers | P910023 |
| FEI number | 2017865 |
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