Reported Nov 1, 2017 · Terminated
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular…
W L Gore & Associates, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: W L Gore & Associates, Inc. · 1500 N Fourth St. · Flagstaff, AZ · 86003-2400
Is this the product you have?
- GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
- Lot codes and dates
- Serial Numbers
146 of 146 codes
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
- Serial Numbers
- Amount recalled
- 12,197units
Why it was recalled
Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
This product could cause temporary or reversible health problems — stop using it.
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