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.
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: 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 BXB061
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- packaging-defect
- sterility-compromise
- heparin-loss
Distribution
Distributed nationwide across the United States.
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