Device recall
Z-1395-2012: 12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to…
FDA device recall · Class II · Spectranetics Corp.
Key facts
| Recall number (Z-number) | Z-1395-2012 |
|---|---|
| Recall event | 61408 |
| Product | 12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation. |
| Product code | LPC |
| Recalling firm | Spectranetics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2012 |
| PMA numbers | P960042 |
| FEI number | 3007284006 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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