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U.S. Department of Health and Human Services

Class 2 Device Recall GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS

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  Class 2 Device Recall GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS see related information
Date Initiated by Firm September 07, 2021
Create Date October 08, 2021
Recall Status1 Open3, Classified
Recall Number Z-0077-2022
Recall Event ID 88721
PMA Number P160021 
Product Classification Iliac covered stent, arterial - Product Code PRL
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:
Code Information Serial Numbers: 22753580
Recalling Firm/
Manufacturer		 W L Gore & Associates, Inc.
3750 W Kiltie Ln
Flagstaff AZ 86005-8712
For Additional Information Contact MPD Customer Care
800-528-8763
Manufacturer 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.
FDA Determined
Cause 2		 Component change control
Action 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).
Quantity in Commerce 2 units
Distribution International distribution to the countries of Italy & Lebanon.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = PRL and Original Applicant = W. L. Gore & Associates, Inc.
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