Z-0077-2022Class II

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE...

Name: Z-0077-2022 Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE...
Creator: W L Gore & Associates, Inc.
Published: 2021-09-07
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2021-09-07 / Open, Classified / root cause: labeling and UDI

FDA source

W L Gore & Associates, Inc. began a recall of 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... on 2021-09-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0077-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-07
Posted: 2021-10-08
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:
Product code: PRL Iliac Covered Stent, Arterial
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.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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 [email protected] 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: [email protected] 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.
Product codes and lots: Serial Numbers: 22753580

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0077-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0077-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-08

Product code PRL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)