CLASS II ONGOING Device recall · Reported 25 Aug 2021 · FDA Enforcement Report

Gore Propaten Vascular Graft configured for Pediatric Shunt recalled

W L Gore & Associates is recalling Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter, Length, distributed in 10 states. The recall was initiated on 12 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2293-2021
FDA event ID: 88245
Recalling firm: W L Gore & Associates, Flagstaff, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 12 May 2021
FDA classified: 13 Aug 2021
Reported: 25 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

12 May 2021	Recall initiated by company
13 Aug 2021	Classified by FDA	+93 days
25 Aug 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Gore 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

Where it was distributed

US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia

Arizona California District of Columbia Georgia Illinois Kentucky Massachusetts Maryland Nebraska Washington

Questions about this recall

Is Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter, Length recalled?

Yes. W L Gore & Associates recalled Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter, Length on 12 May 2021. The recall is Class II and its status is Ongoing. Recall number Z-2293-2021.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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