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GORE TAG THORACIC ENDOPROSTHESIS (2017-09-25)
- Starting date:
- September 25, 2017
- Posting date:
- October 3, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-64692
Affected products
GORE TAG THORACIC ENDOPROSTHESIS
Reason
There were four incomplete deployment events of a Conformable GORE TAG Thoracic Endoprosthesis. Please note that Gore has determined that there is no need for market withdrawal or physical removal of the product. There is no special action needed for any patient who has received this device in the past.
Affected products
GORE TAG THORACIC ENDOPROSTHESIS
Lot or serial number
all lots
Model or catalog number
- TGU212110
- TGU262110
- TGU262610
- TGU282810
- TGU282815
- TGU312610
- TGU313110
- TGU313115
- TGU343410
- TGU343415
- TGU343420
- TGU373710
- TGU373715
- TGU373720
- TGU404010
- TGU404015
- TGU404020
- TGU454510
- TGU454515
- TGU454520
Companies
- Manufacturer
-
W.L. GORE & ASSOCIATES INC
1505 NORTH 4TH STREET
FLAGSTAFF
86004
Arizona
UNITED STATES