Device recall
Z-0928-2013: Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6…
FDA device recall · Class II · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-0928-2013 |
|---|---|
| Recall event | 64344 |
| Product | Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias |
| Product code | MRM |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2015 |
| PMA numbers | P980049, P980049S021, P980049S024 |
| FEI number | 1718850 |
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