Events

Recall of TURBO ELITE CATHETER RX

According to Health Canada (via FOI), this recall involved a device in Canada 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
    52954
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The integrity of the outer sterile packaging may have been compromised.

Device

TURBO ELITE CATHETER RX
  • Model / Serial
    Model Catalog: 417-156 (Lot serial: FBE16E25A); Model Catalog: 414-159 (Lot serial: FBE16E25A); Model Catalog: 410-154 (Lot serial: FBE16E25A); Model Catalog: 414-159 (Lot serial: FBF16E12A); Model Catalog: 414-159 (Lot serial: FBG16E02A); Model Catalog: 410-154 (Lot serial: FBG16E02A); Model Catalog: 417-156 (Lot serial: FBF16E12A); Model Catalog: 410-154 (Lot serial: FBF16E12A); Model Catalog: 417-156 (Lot serial: FBG16E02A); Model Catalog: 114-009 (Lot serial: FTT16D07A)
  • Product Description
    Turbo Elite Catheter RX;Vitesse - COS Escimer laser Ablation Catheter
  • Manufacturer
    SPECTRANETICS CORPORATION

Manufacturer

SPECTRANETICS CORPORATION
  • Manufacturer Address
    COLORADO SPRINGS
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC