Gore Propaten Vascular Graft Pediatric Shunt Diameter Labeling Error
W L Gore is recalling certain Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling. Grafts labeled as 5 mm may actually be 6 mm and vice versa.
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 medical device with diameter labeling error affecting vascular grafts used in pediatric surgery. No adverse events or injuries have been reported. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
W L Gore & Associates, Inc. is recalling certain Gore Propaten Vascular Grafts configured for pediatric shunts due to labeling errors affecting the graft diameter.
The recalled grafts have incorrect diameter labeling: products with an actual 6 mm inner diameter are labeled as 5 mm, and products with an actual 5 mm inner diameter are labeled as 6 mm. The error affects grafts with specific serial numbers and reference numbers HPT060015 and HPT060015A.
The affected grafts were distributed in the United States (NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA) and internationally to Canada, Brazil, Europe, and Saudi Arabia. This is an FDA Class II recall.
Physicians and surgical teams who have received these products should verify the actual graft diameter before use to ensure proper surgical planning and implantation.
The recalled product
- Product
- Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Vascular Graft
- Hazard
- diameter-mislabeling
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 (16)
- 6185502PP002
- 6185502PP003
- 6185502PP004
- 6185502PP006
- 6185502PP007
- 6185502PP009
- 6185502PP010
- 6185503PP001
- 6185503PP002
- 6185503PP004
- 6185503PP005
- 6185503PP006
- 6185503PP007
- 6185503PP008
- 6185503PP009
- 6185503PP010
Distribution
Distributed in 10 states:
- AZ
- CA
- DC
- GA
- IL
- KY
- MA
- MD
- NE
- WA
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