Z-1395-2012

12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction...

Name: Z-1395-2012 12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction...
Creator: Spectranetics Corp.
Published: 2012-03-13
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2012-03-13 / Terminated / root cause: manufacturing process

FDA source

Spectranetics Corp. began a recall of 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... on 2012-03-13. The reason FDA records is "Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1395-2012
Status: Terminated
Initiated: 2012-03-13
Posted: 2012-04-11
Terminated: 2012-05-02
Recalling firm: Spectranetics Corp.
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 Device, Angioplasty, Laser, Coronary
Reason for recall: Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: C11H25B C11H25C C11H25D C11H29E C11H29F C11H29G C11J06A C11J06B C11J06C C11J06D C11J12A C11J12B C11J21E C11J22F C11J29A C11J29B C11J29C C11K03E C11K06A C11K06B C11K06C F11J19A F11J29F F11K11D F11K25G F11L03A and F11L17A

Product code LPC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)