FDA Medical Device Recalls (openFDA)
W L Gore & Associates, Inc.: 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:
- Recall number
- Z-0077-2022
- Recalling firm
- W L Gore & Associates, Inc.
- 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:
- Status
- Open, Classified
- Initiated
- 2021-09-07
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- 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
- 2 units
- Distribution
- International distribution to the countries of Italy & Lebanon.
- Lot, serial or model codes
- Serial Numbers: 22753580
- 510(k) numbers
- not on file
- PMA numbers
- ["P160021"]
- Product code
- PRL
- Firm FEI
- 2017233
- Firm city
- Flagstaff
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28