Gore Propaten Vascular Graft configured for Pediatric Shunt — Class II medical device recall Z-2292-2021
Ongoing recall by W L Gore & Associates, Inc., reported 2021-08-25, distributed in AZ, CA, DC, GA, IL, KY, MA, MD…. Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts co
| Recall number | Z-2292-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W L Gore & Associates, Inc., Flagstaff, AZ, United States |
| Recall initiated | 2021-05-12 |
| Classified | 2021-08-13 |
| Reported by FDA | 2021-08-25 |
| Distributed | AZ, CA, DC, GA, IL, KY, MA, MD, NE, WA |
| Countries outside the US | BR, CA, SA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00733132606320, 00733132606337 |
| Serial numbers | 6185494PP001, 6185494PP002, 6185494PP004, 6185494PP006, 6185494PP008, 6185494PP009, 6185494PP010, 6185494PP011, 6185494PP012, 6185495PP001, 6185495PP002, 6185495PP004, 6185495PP005, 6185495PP006, 6185495PP007, 6185495PP009, 6185495PP010, 6185495PP011, 6185495PP012, 6185495PP014, 6185497PP001, 6185497PP005, 6185497PP006, 6185497PP007, 6185497PP008 and 6 more |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2292-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.