Devices

Device Recall 12Fr SLS II Laser Sheath

Model / Serial
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 Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
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 Description
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.
Manufacturer
Spectranetics Corp.
1 Event
- Recall of Device Recall 12Fr SLS II Laser Sheath

Manufacturer

Spectranetics Corp.

Manufacturer Address
Spectranetics Corp., 9965 Federal Drive, Colorado Springs CO 80921-3617
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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