GORE MOLDING AND OCCLUSION BALLOON CATHETER (2021-07-09)

Starting date:
July 9, 2021
Posting date:
July 20, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76059

Last updated:

Affected Products 

GORE MOLDING AND OCCLUSION BALLOON CATHETER

Reason

W. L. Gore & Associates Canada, Inc. (Gore) received complaints regarding GORE® Molding and Occlusion Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation or use of the device, resulting in either insufficient inflation or an inability to inflate.

Affected products

GORE MOLDING AND OCCLUSION BALLOON CATHETER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MOB37

Companies
Manufacturer
W.L. GORE & ASSOCIATES INC
1505 NORTH 4TH STREET
FLAGSTAFF
86004
Arizona
UNITED STATES