Recall Z-2945-2024
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: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
Codes / lots: Lot Serial Number/UDI: 27884430 00733132658251 27884431 00733132658251 27884432 00733132658251 27884433 00733132658251 27884434 00733132658251 27884435 00733132658251 27884436 00733132658251 27884437 00733132658251 27884438 00733132658251 27884439 00733132658251 27884440 00733132658251 27884441 00733132658251 27884442 00733132658251 27884443 00733132658251 27884444 00733132658251 27884445 00733132658251 28325852 00733132658251 28325853 00733132658251 28325854 00733132658251 28325856 00733132658251 28325857 00733132658251 28431071 00733132658251 28431072 00733132658251 28431073 00733132658251 28547558 00733132658251 28547559 00733132658251 28547560 00733132658251 28691206 00733132658251 28691207 00733132658251 28691208 00733132658251 28691209 00733132658251 28928606 00733132658251 28928607 00733132658251 28928608 00733132658251 28928609 00733132658251 28928610 00733132658251 28928611 00733132658251 28928612 00733132658251 28928613 00733132658251 28961589 00733132658251 28961590 00733132658251 28961591 00733132658251 29039475 00733132658251 29039476 00733132658251 29039477 00733132658251 29039478 00733132658251 29039479 00733132658251 28356298 00733132658268 27713024 00733132658268…
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-2945-2024
- Initiated
- July 1, 2024
- Posted by FDA
- August 30, 2024
- Product code
- PRL – Iliac Covered Stent, Arterial
- Quantity
- 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, 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-2946-2024 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 |