CanadaThe Gore Tag Thoracic Branch Endoprosthesis Side Branch Component (model TSB081206A) with lot/serial numbers 31410725, 31342365, 31616748, 31345619, and 31345618 is affected. It was recalled because of catheter separation of the side branch component during clinical use; contact the manufacturer for additional information.
What's being recalled
Companies: W.L. Gore & Associates Inc, Medical West, Flagstaff, Arizona, United States, 86004.
How to identify it
Affected products: Gore® Tag® Thoracic Branch Endoprosthesis Side Branch Component; Lot or serial number: 31410725; Model or catalogue number: TSB081206A
Affected products: Gore® Tag® Thoracic Branch Endoprosthesis Side Branch Component; Lot or serial number: 31342365; Model or catalogue number: TSB081206A
Affected products: Gore® Tag® Thoracic Branch Endoprosthesis Side Branch Component; Lot or serial number: 31616748; Model or catalogue number: TSB081206A
Affected products: Gore® Tag® Thoracic Branch Endoprosthesis Side Branch Component; Lot or serial number: 31345619; Model or catalogue number: TSB081206A
Affected products: Gore® Tag® Thoracic Branch Endoprosthesis Side Branch Component; Lot or serial number: 31345618; Model or catalogue number: TSB081206A
The hazard
Catheter separation of the Gore® Tag® Thoracic Branch Endoprosthesis (TBE) Side Branch (SB) component during clinical use.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)