Events

Recall of CRUISER HYDRO F

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOTRONIK CANADA 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
    20140
  • Event Risk Class
    II
  • Event Initiated Date
    2011-09-09
  • 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
    Specific lots potentially have decreased tensile strength of the distal tip when tested at three year shelf-life. two year shelf-life dated product is not affected.

Device

CRUISER HYDRO F
  • Model / Serial
    Model Catalog: 351456 (Lot serial: >10 numbers contact mfg); Model Catalog: 351455 (Lot serial: >10 numbers contact mfg); Model Catalog: 351457 (Lot serial: 01109002); Model Catalog: 351457 (Lot serial: 08099006); Model Catalog: 351457 (Lot serial: 10099008); Model Catalog: 351457 (Lot serial: 10099007); Model Catalog: 351457 (Lot serial: 01109001); Model Catalog: 351459 (Lot serial: 02109003); Model Catalog: 351459 (Lot serial: 9099001); Model Catalog: 351459 (Lot serial: 10099001); Model Catalog: 351459 (Lot serial: 10099003); Model Catalog: 351458 (Lot serial: >10 numbers contact mfg)
  • Product Description
    CRUISER HYDRO CORONARY AND PERIPHERAL ARTERY GUIDE WIRE F
  • Manufacturer
    BIOTRONIK CANADA INC

Manufacturer

BIOTRONIK CANADA INC
  • Manufacturer Address
    TORONTO
  • Manufacturer Parent Company (2017)
    Ms Holding Ii Se
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    HC