Events

Recall of Device Recall Laser Guide Catheter

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

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
    59382
  • Event Risk Class
    Class 2
  • Event Number
    Z-2951-2011
  • Event Initiated Date
    2011-07-18
  • Event Date Posted
    2011-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102449
  • 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
    Catheter, percutaneous - Product Code DQY
  • Reason
    Packaging integrity may be compromised, thus sterility can not be assured.
  • Action
    Spectranetics sent an "PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product. Further information is available at +011.49.719.447.2539.

Device

Device Recall Laser Guide Catheter
  • Model / Serial
    Lot Numbers: CTB09K14A, FTB09L25C, FTB09M01A, FTB09M02A, FTB10B10B, FTB10F28A, FTB10G12A.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.
  • Product Description
    Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. || Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
  • Manufacturer
    Spectranetics Corporation

Manufacturer

Spectranetics Corporation
  • Manufacturer Address
    Spectranetics Corporation, 96 Talamine Ct, Colorado Springs CO 80907-5159
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA