Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLB
Summary
The FDA issued a Class II for Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 by W L Gore & Associates, Inc.. 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..
Details
Source
Device Recall
External ID
Z-0077-2022
Action Date
2021-10-20
Status
Ongoing
Category
device
Product Description
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:
Lot/Code Info: Serial Numbers: 22753580
Quantity Affected: 2 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-07
Company
Flagstaff, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
W L Gore & Associates, Inc. has 25 FDA actions in our database, including 20 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (W L Gore & Associates, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does W L Gore & Associates, Inc. have FDA actions?
W L Gore & Associates, Inc. has 25 FDA actions in our database, including 20 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0077-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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