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Lower risk Medical device recall · FDA · Published May 12, 2021

Gore Pediatric Vascular Grafts May Be Mislabeled - Risk of Incorrect Size

Gore recalls pediatric vascular grafts that may be incorrectly labeled as 5mm or 6mm. This could lead to improper medical use if the wrong size is used during surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2292-2021Medical deviceGore ›
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Recalling firmW L Gore & Associates, Inc.3750 W Kiltie Ln · Flagstaff, AZ 86005-8712
✎ GovInfoNow plain-language explainer

Gore is recalling pediatric vascular grafts that may be mislabeled as 5mm when they are actually 6mm or vice versa. Using the wrong size could cause improper medical procedures during surgery. Read more at govinfonow.com/recall/62554-gore-pediatric-vascular-grafts-may-be-mislabeled-risk-of-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/62554-gore-pediatric-vascular-grafts-may-be-mislabeled-risk-of-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2292-2021

Cite this page

“Gore Pediatric Vascular Grafts May Be Mislabeled - Risk of Incorrect Size.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62554-gore-pediatric-vascular-grafts-may-be-mislabeled-risk-of-incorrect. Based on FDA recall #Z-2292-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2292-2021%22&limit=1).

The FDA announced on May 12, 2021, that W L Gore & Associates, Inc. is recalling Gore Propaten Vascular Grafts configured for Pediatric Shunt due to incorrect labeling of inner diameters. The agency stated the recall is voluntary and initiated by the firm.

How to tell if you have it

  • Brand: Gore
  • Product: Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO
  • UPC: 00733132606320
  • UPC: 00733132606337
  • Reference Number: HPT050010 UDI: (01)00733132606320
  • Reference Number: HPT050010A UDI: (01)00733132606337
  • Serial Numbers for HPT050010A: 6185494PP001, 6185494PP002, 6185494PP004, 6185494PP006, 6185494PP008, 6185494PP009, 6185494PP010, 6185494PP011, 6185494PP012, 6185495PP001, 6185495PP002, 6185495PP004, 6185495PP005, 6185495PP006, 6185495PP007, 6185495PP009, 6185495PP010, 6185495PP011, 6185495PP012, 6185495PP014
  • Serial Numbers for HPT050010: 6185497PP001, 6185497PP005, 6185497PP006, 6185497PP007, 6185497PP008, 6185497PP009, 6185497PP010, 6185497PP011, 6185497PP012

The hazard

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, according to the FDA.

Context

GovInfoNow's records show W L Gore & Associates, Inc. has 18 other recalls on record since 2017-09-25. Other recent recalls of similar products include Micro Therapeutics Pipeline Flex Embolization Device: Incorrect Labeling Risk (2026-06-08), Micro Therapeutics Pipeline Flex Embolization Device Recall: Incorrect Diameter Label (2026-06-25) and LeMait: Artegraft Vascular Graft Recall Due to Labeling Mix-Up (2026-02-10).

How to tell if you have this one

Check for the reference numbers HPT050010 or HPT050010A with specific serial numbers listed in the recall notice. These grafts are for pediatric shunts only and require a prescription.

  • Brand
    Gore
  • Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia
Recall numberProduct, codes & lots
Z-2292-2021Gore 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; 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
Z-2293-2021Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375; Serial Number for HPT060015A: 6185496PP001 and Serial Numbers for HPT060015: 6185502PP001, 6185502PP002, 6185502PP003, 6185502PP004, 6185502PP006, 6185502PP007, 6185502PP009, 6185502PP010, 6185503PP001, 6185503PP002, 6185503PP004, 6185503PP005, 6185503PP006, 6185503PP007, 6185503PP008, 6185503PP009, 6185503PP010
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the reference numbers HPT050010 or HPT050010A with the specific serial numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 9 states and D.C., and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: yesDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, District of Columbia, Georgia, Illinois, Kentucky, Maryland, Massachusetts, Nebraska, Washington.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: May 12, 202112. FDA classified it Class II: Aug 13, 202123. Published in FDA’s Enforcement Report: Aug 25, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are these grafts safe to use?

The recall indicates a potential mislabeling risk, but the grafts are generally safe if used correctly with the proper size.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2292-2021 (May 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2292-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA