Events

Recall of TWIN-PASS DUAL ACCESS CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VASCULAR SOLUTIONS 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
    105073
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-21
  • 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
    Investigation of recent device experience reports has made vascular solutions inc. (vsi) aware of a potential problem with the twin-pass(5200) twin-pass rx (5210) and twin-pass .023" (5230) dual access catheters. vascular solutions has concluded there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. it is possible that the excess material may separate from the catheter during a procedure which poses a potential risk of embolism to the patient.

Device

TWIN-PASS DUAL ACCESS CATHETER
  • Model / Serial
    Model Catalog: 5200 (Lot serial: >10 numbers contact mfg.); Model Catalog: 5230 (Lot serial: >10 numbers contact mfg.)
  • Product Description
    TWIN-PASS DUAL ACCESS CATHETER
  • Manufacturer
    VASCULAR SOLUTIONS INC.

Manufacturer

VASCULAR SOLUTIONS INC.