Events

Recall of Device Recall Visualase(TM) Cooled Laser Applicator System (VCLAS) 15MM TIP

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

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
    77623
  • Event Risk Class
    Class 2
  • Event Number
    Z-2755-2017
  • Event Initiated Date
    2017-06-07
  • Event Date Posted
    2017-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156887
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Medtronic has become aware that the vclas 15mm tip cap, also referred to as tuohy borst adapter (tba), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. when the tba is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the tba.
  • Action
    Medtronic sent an Urgent Medical Device Safety Alert dated June 1, 2017, to all affected customers. Actions to be taken: 1. Please examine your inventory and if any of the affected products listed above are found, immediately quarantine them for return to Medtronic. 2. Complete and follow instruction on the attached consignee response form. Sign and date the bottom of the form and then return the form to Medtronic at RS.NavFCA¿medtronic.com or fax to Medtronic Technical Services at 651-367-7075. If you have affected products, contact Medtronic Technical Services at 1-800 595-9709 to receive a return material authorization (RMA) and arrange for their return and no charge replacements. Once an RMA number is obtained, ship the affected product to Medtronic. For further questions please call (720) 890-3241.

Device

Device Recall Visualase(TM) Cooled Laser Applicator System (VCLAS) 15MM TIP
  • Model / Serial
    Lot Numbers: 211158059, 211560973, 211959879, 12473141, 212707035, 211158151, 211594328, 211977586, 212503634, 212745660, 211158152, 211599898, 211987873, 212504463, 212796559, 211181212, 211628257, 212127654, 212549456, 212912501, 211181547,211908695, 212141557, 212553428, 211184941, 211916062, 212148368, 212632884,211555011, 211926889, 212434500, 212647830, 211555017, 211950736, 212438405, 212701679
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX
  • Product Description
    Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • Manufacturer Address
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA