FDA Medical Device Recalls (openFDA)
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 number
- Z-2292-2021
- Recalling firm
- W L Gore & Associates, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2021-05-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- not on file
- Distribution
- US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K062161"]
- PMA numbers
- not on file
- Product code
- DSY
- Firm FEI
- 2017233
- Firm city
- Flagstaff
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28