The Recall Desk
HighFDA (Devices)·Z-2946-2024·Announced 2024-09-11

W L Gore Recalls Heparin Viabahn VBX Endoprosthesis Due to Packaging Defects

W L Gore & Associates is recalling specific lots of Heparin, Gore Viabahn VBX Balloon Expandable Endoprosthesis because packaging defects may compromise sterility and heparin activity.

What this means for you

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: The recall involves a medical device where sterility and drug activity may be compromised, representing a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

W L Gore & Associates, Inc. is recalling 100 units of Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis. The recall affects specific reference numbers and lot serial numbers distributed nationwide in the United States and in Japan. The product is intended for clinical use.

The recall was initiated due to packaging defects that may compromise sterility assurance and heparin activity. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

Healthcare providers and patients should check their inventory and patient records for the affected lot serial numbers and reference numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or the distributor in accordance with the recall instructions.

The recalled product

Product
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *Fo
Manufacturer
W L Gore & Associates, Inc.
Category
Medical Device — Endoprosthesis
Hazard
Affected units
100

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 (20)

  • Lot Serial Number/UDI: 27342032/00733132658053
  • 27342035/00733132658053
  • 27342038/00733132658053
  • 27342047/00733132657926
  • 27342078/00733132657940
  • 27342079/00733132657940
  • 27342102/00733132657957
  • 27342104/00733132657957
  • 27342108/00733132657957
  • 27342253/00733132657964
  • 27342255/00733132657964
  • 27342256/00733132657964
  • 27342257/00733132657964
  • 27342258/00733132657964
  • 27342259/00733132657964
  • 27342260/00733132657964
  • 27342261/00733132657964
  • 27342262/00733132657964
  • 27342263/00733132657964
  • 27342264/00733132657971

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 2 recalled by W L Gore & Associates, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · W L Gore & Associates, Inc.

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Same hazard · sterility compromise

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