Events

Recall of SONIC - BRAIDED MICROCATHETER WITH GUIDEWIRE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by YOCAN MEDICAL SYSTEMS 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
    48035
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-07
  • 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
    Balt extrusion received complaints related to ruptures or inflations of sonic microcatheters during the injections of contrast liquid or embolic agents. sonic microcatheters are designed to be thin and very flexible which allows them to reach very distal locations. special attention must be given during the injections in order to avoid any complications related to overpressure. hence a customer letter was created and is being distributed to remind users to follow the instructions in the ifu to prevent incidents due to overpressure.

Device

SONIC - BRAIDED MICROCATHETER WITH GUIDEWIRE
  • Model / Serial
    Model Catalog: SONIC 1.5F15 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F35 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F15SG (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F/15 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F/25 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.5F15SG (Lot serial: ALL LOTS)
  • Product Description
    SONIC - BRAIDED MICROCATHETER WITH PROGRESSIVE SUPPLENESS
  • Manufacturer
    YOCAN MEDICAL SYSTEMS INC.

Manufacturer

YOCAN MEDICAL SYSTEMS INC.