Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gore Propaten Vascular Graft configured for Pediatric Shunt Recalled by W L Gore & Associates, Inc. Due to Vascular Grafts containing an inner diameter of 6...
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
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
Quantity: N/A
Why Was This Recalled?
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Where Was This Sold?
This product was distributed to 10 states: AZ, CA, GA, IL, KY, MD, MA, NE, WA, DC
About W L Gore & Associates, Inc.
W L Gore & Associates, Inc. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report