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Terminated

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.

FDA Recall Z-1395-2012 · Posted 2012-04-11

Recalling FirmSpectranetics Corp.
Recall StatusTerminated
Product CodeLPC
Date Initiated2012-03-13
Date Terminated2012-05-02
Product Quantity615

Reason for Recall

Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.

Firm 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).

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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