Recall Z-2946-2024
W L Gore & Associates, Inc. · initiated July 1, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Serial Number/UDI: 27342032/00733132658053; 27342035/00733132658053; 27342038/00733132658053; 27342047/00733132657926; 27342078/00733132657940; 27342079/00733132657940; 27342102/00733132657957; 27342104/00733132657957; 27342108/00733132657957; 27342253/00733132657964; 27342255/00733132657964; 27342256/00733132657964; 27342257/00733132657964; 27342258/00733132657964; 27342259/00733132657964; 27342260/00733132657964; 27342261/00733132657964; 27342262/00733132657964; 27342263/00733132657964; 27342264/00733132657971; 27342266/00733132657971; 27342267/00733132657971; 27342268/00733132657971; 27342269/00733132657971; 27342270/00733132657971; 27342290/00733132657988; 27342333/00733132657995; 27342334/00733132657995; 27342335/00733132657995; 27342336/00733132657995; 27342337/00733132657995; 27342338/00733132657995; 27342339/00733132657995; 27342340/00733132657995; 27342341/00733132657995; 27342342/00733132657995; 27342343/00733132657995; 27342344/00733132657995; 27342345/00733132657995; 27342346/00733132657995; 27342347/00733132657995; 27342349/00733132657995; 27342350/00733132657995; 27342352/00733132657995; 27342403/00733132658008; 27342535/00733132658015; 27342536/00733132658015…
Reason for recall
Due to packaging defects, sterility assurance and heparin activity may be compromised.
FDA-determined cause: Package design/selection
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.
Details
- Recall number
- Z-2946-2024
- Initiated
- July 1, 2024
- Posted by FDA
- August 30, 2024
- Product code
- PRL – Iliac Covered Stent, Arterial
- Quantity
- 100 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, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
- Recalling firm
- W L Gore & Associates, Inc., Flagstaff, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2945-2024 Class II | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following…Due to packaging defects, sterility assurance and heparin activity may be compromised. | 07/01/2024Open, Classified |