Recall Z-1395-2012 ยท LPC Device, Angioplasty, Laser, Coronary
Spectranetics Corp.
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.
| Date | Apr 11, 2012 (initiated Mar 13, 2012) |
| Status | Terminated |
| Reason | Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket. |
| Root cause | Nonconforming Material/Component |
| Action | Spectranetics sent Recall Notices to all customers on March 14, 2012. The product issue was described and requested actions were included. Questions were directed to Customer Service at 1-800-231-0978 (US). |
| Quantity | 615 |
| Distribution | Worldwide Distribution -- USA , and the countries of Australia, Belgium, Canada, Czech Republic, France, Germany, Italy, Ireland, Japan, Netherlands, Russia, Sweden, Switzerland, United Kingdom and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.