Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall
W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.
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: This FDA Class II recall involves mislabeling of critical product dimensions on a pediatric surgical device. The dimension error creates a risk that an incorrectly sized graft could be implanted, which could compromise patient outcomes. With no reported injuries but clear risk-of-harm potential, this meets the High severity threshold.
Plain-English summary
W L Gore & Associates is recalling certain Gore Propaten Vascular Grafts configured for pediatric shunts, including Reference numbers HPT050010 and HPT050010A, due to labeling inaccuracy. Grafts containing a 6 mm inner diameter are incorrectly labeled as 5 mm, while grafts containing a 5 mm inner diameter are incorrectly labeled as 6 mm.
The dimension mislabeling poses a risk that an incorrectly sized graft could be surgically implanted, potentially compromising graft function and patient outcomes.
The recall affects units distributed in the United States (including the Northeast, District of Columbia, Massachusetts, Kentucky, Illinois, Washington, Maryland, California, Arizona, and Georgia) as well as internationally in Canada, Brazil, Europe, and Saudi Arabia.
Specific serial numbers for the recalled products are identified in the recall notice and should be verified before use.
The recalled product
- Product
- 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
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Vascular Graft
- Hazard
- mis-labeling
- dimension-error
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 (20)
- Serial Numbers for HPT050010A: 6185494PP001
- 6185494PP002
- 6185494PP004
- 6185494PP006
- 6185494PP008
- 6185494PP009
- 6185494PP010
- 6185494PP011
- 6185494PP012
- 6185495PP001
- 6185495PP002
- 6185495PP004
- 6185495PP005
- 6185495PP006
- 6185495PP007
- 6185495PP009
- 6185495PP010
- 6185495PP011
- 6185495PP012
- 6185495PP014 and Serial Numbers for HPT050010: 6185497PP001
Distribution
Distributed in 10 states:
- AZ
- CA
- DC
- GA
- IL
- KY
- MA
- MD
- NE
- WA
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