Class 2 Device Recall Gore Propaten Vascular Graft

• Date Initiated by Firm: May 12, 2021
• Create Date: August 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2292-2021
• Recall Event ID: 88245
• 510(K)Number: K062161
• Product Classification: Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: W L Gore & Associates, Inc.; 3750 W Kiltie Ln; Flagstaff AZ 86005-8712
• For Additional Information Contact: MPD Customer Care; 800-528-8763
• Manufacturer 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.
• FDA Determined 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 FieldActionTeam@wlgore.com 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: medcomplaints@wlgore.com, 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: MPDCustomerCare@wlgore.com) or Uzma Tahir, Ph.D. (928-864-3779/utahir@wlgore.com) 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DSY