Events

Recall of Device Recall 12Fr SLS II Laser Sheath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spectranetics Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61408
  • Event Risk Class
    Class 2
  • Event Number
    Z-1395-2012
  • Event Initiated Date
    2012-03-13
  • Event Date Posted
    2012-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108018
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, angioplasty, laser, coronary - Product Code LPC
  • Reason
    Isolated lots of the 12fr sls ii laser sheath can have a split in the outer jacket.
  • 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).

Device

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.

Manufacturer

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