Device product
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
Z-0077-2022
Product summary
- Event
- Event 88721
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0077-2022
Official wording
Reason: Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Code information: Serial Numbers: 22753580
Distribution pattern: International distribution to the countries of Italy & Lebanon.
Derived failure modes
-
Labeling or packaging
Incorrect labeling