This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Cloversnare 4-Loop Vascular Retriever (2014-07-14)

Starting date:
July 14, 2014
Posting date:
August 8, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40819

Recalled products

  1. Cloversnare 4-Loop Vascular Retriever 

Reason

We have received reports of instances where the snare loop has separated from the shaft of the device. The issue appears to be related to/caused when lateral forces are applied to the loop/shaft connection (e.g. In three reports, separation occurred after attempts by a user to reshape the tip of the device). The issue was uncovered during a customer complaint investigation.

Affected products

A. Cloversnare 4-Loop Vascular Retriever

Lot or serial number
  • 4319577
  • 4319579
  • 4319581
  • 4319583
Model or catalog number
  • VRS-6.0-90
Companies
Manufacturer
Cook Incorporated
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES