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:
2021-07-20

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  Reason
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  Affected products

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