Events

Recall of STEERABLE GUIDEWIRE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    43345
  • Event Risk Class
    II
  • Event Initiated Date
    2006-07-31
  • 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
    It was recently determined that guidewires within the affected lots of sv-5 and sv-8 peripheral steerable guidewires may have a potential for guidewire fracture resulting in tip separation.

Device

STEERABLE GUIDEWIRE
  • Model / Serial
    Model Catalog: 503-658X (Lot serial: >10 LOT NUMBERS); Model Catalog: 503-558 (Lot serial: >10 LOT NUMBERS); Model Catalog: 503-558X (Lot serial: >10 LOT NUMBERS); Model Catalog: 503-658 (Lot serial: >10 LOT NUMBERS); Model Catalog: 503-558 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 503-558X (Lot serial: CONTACT MANUFACTURER); Model Catalog: 503-658X (Lot serial: CONTACT MANUFACTURER); Model Catalog: 503-658 (Lot serial: CONTACT MANUFACTURER)
  • Product Description
    CORDIS PERIPHERAL STEERABLE GUIDEWIRES
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.