Device recall
Z-0801-05: Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a…
FDA device recall · Class II · ela Medical Llc
Key facts
| Recall number (Z-number) | Z-0801-05 |
|---|---|
| Recall event | 31539 |
| Product | Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and… |
| Product code | LWS |
| Recalling firm | ela Medical Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2006 |
| PMA numbers | P970024 |
| FEI number | 2182863 |
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