Heparin Gore Viabahn VBX Endoprosthesis Recalled for Packaging Defects
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
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: FDA Class II recall with no reported illnesses or injuries. The stated hazard is theoretical—packaging defects 'may' compromise sterility and heparin activity rather than confirmed harm—placing it at Score 3 per the rubric's guidance for recalls without reported injuries and theoretical risk.
Plain-English summary
W L Gore & Associates, Inc. is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices in multiple affected lot numbers. Approximately 42,901 units were distributed worldwide, including throughout all U.S. states and Japan.
The recall was initiated due to packaging defects that may compromise sterility assurance and heparin activity of the affected devices.
The FDA classified this as a Class II recall.
The recalled product
- Product
- Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A…
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 42,901
Distribution
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
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