W L Gore & Associates, Inc.: Device Recall

Recall Details

Recall Number

Z-2946-2024

Classification

Class II

Product Type

Device

Recalling Firm

W L Gore & Associates, Inc.

Status

Ongoing

Date Initiated

07/01/2024

Location

Flagstaff, AZ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

100 units

Reason for Recall

Due to packaging defects, sterility assurance and heparin activity may be compromised.

Product Description

Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.

Other Recalls by W L Gore & Associates, Inc.

• Class II: Risk 08/26/2025
  Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
• Class II: Risk 07/03/2024
  Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
• Class II: Risk 07/01/2024
  Due to packaging defects, sterility assurance and heparin activity may be compromised.

View all recalls by W L Gore & Associates, Inc. →