Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051

FDA device recall Z-2945-2024 · posted 2024-08-30 · Open, Classified

Recall details

Recalling firm

W L Gore & Associates, Inc.

Reason for recall

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

Action taken

Between the dates of July 18-19,2024 , W.L. Gore issued a "Urgent Medical Device Correction" notification to affected consignees either via UPS or hand delivery. W.L. Gore asked consignees to take the following actions: 1. For US Only, per the IFU, carefully inspect the foil pouch to ensure that it is not compromised. Do not use the GORE VIABAHN VBX Balloon Expandable Endoprosthesis if the foil pouch is compromised. Do not use the GORE VIABAHN VBX Balloon Expandable Endoprosthesis if the sterile pouch is compromised. This warning includes the Compliance Chart embedded in the seal or a damaged/cut Compliance Chart. 2. Open the foil pouch, and gently remove the coil containing the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis and the Compliance Chart. Carefully inspect the Compliance Chart to ensure that it is not damaged. Do not use the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis if the Compliance Chart cannot be removed from the pouch or is damaged as the Compliance Chart may have been embedded in the seal. Reference sample images below. 3. Implanting Physicians: If you suspect you have implanted a potentially compromised Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis device, please be mindful of the potential health outcomes and plan to take the needed measures that could minimize any potential health hazard/risk/harms associated with a compromised sterile barrier. 4. Please complete and sign the enclosed ACKNOWLEDGEMENT FORM and return to WLGore7011@sedgwick.com within 2 weeks of receipt of this notification. This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). On 10/25/24, additional correction notices were sent to customers informing them that additional devices were found to be affected.

Root cause

Package design/selection

Status

Open, Classified

Product code

PRL

Quantity affected

42,901 units

Distribution

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

Date initiated

2024-07-01

Date posted

2024-08-30

Location

Flagstaff, AZ