Gore VIABAHN VBX endoprosthesis recalled for incorrect device dimension labeling
W L Gore & Associates is recalling GORE VIABAHN VBX balloon expandable endoprosthesis units due to labeling showing incorrect device dimensions. Two units with specification mismatches were distributed to Italy and Lebanon.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device specification mismatch. The actual device dimensions differ from labeled specifications, representing a risk of harm in clinical use. No illnesses or injuries have been reported. This fits the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
W L Gore & Associates is recalling specific units of GORE VIABAHN VBX, a balloon-expandable vascular endoprosthesis used in medical procedures.
The recall is due to labeling that does not match the actual device. The affected units are labeled as 8 mm x 59 mm x 135 cm but actually contain a 9 mm x 29 mm x 135 cm device. This mismatch between labeled specifications and actual device dimensions could result in incorrect device selection during medical procedures. The affected serial number is 22753580.
Two units with incorrect labeling were distributed internationally to Italy and Lebanon.
Healthcare facilities that received these units should verify product serial numbers and contact W L Gore & Associates regarding the specification discrepancy and proper device identification before use.
The recalled product
- 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:
- Manufacturer
- W L Gore & Associates, Inc.
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 22753580
Distribution
Distribution scope not specified by the agency.
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