Z-2292-2021Class II

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile...

Name: Z-2292-2021 Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile...
Creator: W L Gore & Associates, Inc.
Published: 2021-05-12
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2021-05-12 / Open, Classified / root cause: labeling and UDI

FDA source

W L Gore & Associates, Inc. began a recall of Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010... on 2021-05-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2292-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-12
Posted: 2021-08-13
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
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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: [email protected], 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: [email protected]) or Uzma Tahir, Ph.D. (928-864-3779/[email protected]) if you have questions or concerns regarding this voluntary recall.
Distribution: US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2292-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2292-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-13
Z-2293-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-13

Product code DSY

K062161Class IIGore Propaten Vascular GraftW. L. Gore & Associates, Inc. / cleared 2006-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)