FDA Device recall Z-2292-2021
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference…
- FDA Device
- Class II
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference… by W L Gore And Associates, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2292-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-12 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | W L Gore And Associates |
| Distribution | AZ, CA, DC, GA, IL, KY, MA, MD, NE, WA |
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
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.
Identifiers
| code_info | Serial Numbers for HPT050010A: 6185494PP001, 6185494PP002, 6185494PP004, 6185494PP006, 6185494PP008, 6185494PP009, 6185…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2292-2021%22
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