Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Heparin Recalled by W L Gore & Associates, Inc. Due to Due to packaging defects, sterility assurance and heparin...

Date: July 1, 2024
Company: W L Gore & Associates, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact W L Gore & Associates, Inc. directly.

Affected Products

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 *For Clinical use.

Quantity: 100 units

Why Was This Recalled?

Due to packaging defects, sterility assurance and heparin activity may be compromised.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About W L Gore & Associates, Inc.

W L Gore & Associates, Inc. has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report