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:
- Company
- W L Gore & Associates, Inc.
- Recall Initiated
- September 7, 2021
- Recall Number
- Z-0077-2022
- Quantity
- 2 units
- Firm Location
- Flagstaff, AZ
Reason for Recall
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.
Distribution
International distribution to the countries of Italy & Lebanon.
Lot / Code Info
Serial Numbers: 22753580
Root Cause
Component change control
Action Taken
On September 9, 2021, Gore issued a "Urgent Field Safety Notice" to affected consignees via E-Mail. In addition to informing consignees about the recalled product, Gore asked consignees to take the following actions: 1. Identify and return the device listed in the CHANNEL PARTNER RESPONSE FORM if unused. 2. Please complete and sign the enclosed CHANNEL PARTNER RESPONSE FORM and return to FieldActionTeam@wlgore.com within 2 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. 4. If a listed device has been implanted, there is no patient-follow up needed and there are no further actions needed other than informing Gore the device was used. Please indicate the used device on the CHANNEL PARTNER RESPONSE FORM and return to FieldActionTeam@wlgore.com within 2 weeks of receipt of this letter. No further action is needed. 5. Any adverse event involving the GORE VIABAHN VBX Balloon Expandable Endoprosthesis should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to W. L. Gore & Associates, email: medcomplaints@wlgore.com or contact: EMEA: +49 89 4612 3440, Fax: +49 89 4612 43440 6. This notice needs to be passed on to all those who need to be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). Please transfer this notice to other organization(s) on which this action has an impact (as appropriate).