W L Gore & Associates, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
W L Gore & Associates, Inc.
Lot Codes / Batch Numbers
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, 6185497PP005, 6185497PP006, 6185497PP007, 6185497PP008, 6185497PP009, 6185497PP010, 6185497PP011, 6185497PP012
Products Sold
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, 6185497PP005, 6185497PP006, 6185497PP007, 6185497PP008, 6185497PP009, 6185497PP010, 6185497PP011, 6185497PP012
W L Gore & Associates, Inc. is recalling Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 10, 2021, Gore issued a "Medical Device Recall" notification to affected customers via USPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. 2. Please complete and sign the enclosed CUSTOMER RETURN FORM and return to FieldActionTeam@wlgore.com within 2 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. Please transfer this notice to other organization(s) as appropriate. 4. Any adverse event involving the GORE PROPATEN Vascular Graft configured for Pediatric Shunt should be reported to the manufacturer and the country specific regulatory authorities immediately. A. To report an event to W. L. Gore & Associates, email: medcomplaints@wlgore.com, or contact: USA: +1 800 528 1866 Ext. 44922 / +1 928 864 4922, Fax +1 928 864 4364 EMEA: +49 89 4612 3440, Fax +49 89 4612 43440 Brazil: +55 11 5502-7953, Fax: +55 11 5502-7965 B. For US Customers only: Healthcare professionals and consumers may report adverse events or quality problems directly to FDA using the FDA MedWatch Website:https://www.accessdata.fda.gov/scripts/medwatch/index.cfm 5. Please feel free to contact Gore Customer Service (email: MPDCustomerCare@wlgore.com) or Uzma Tahir, Ph.D. (928-864-3779/utahir@wlgore.com) if you have questions or concerns regarding this voluntary recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, GA, IL, KY, MD, MA, NE, WA, DC
Page updated: Jan 10, 2026