| | Class 2 Device Recall Gore Viabahn VBX, Balloon Expandable Endoprosthesis |  |
| Date Initiated by Firm | July 01, 2024 |
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| Date Posted | August 30, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2946-2024 |
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| Recall Event ID |
94971 |
| Product Classification |
Iliac covered stent, arterial - Product Code PRL
|
| 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. |
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| Code Information |
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;
27342571/00733132658022;
27342572/00733132658022;
27342585/00733132658039;
27342586/00733132658039;
27342587/00733132658039;
27342591/00733132658039;
27342624/00733132658046;
27342626/00733132658046;
27342627/00733132658046;
27342628/00733132658046;
27399807/00733132658053;
27399808/00733132658053;
27399814/00733132658053;
27399815/00733132658053;
27399816/00733132658053;
27399883/00733132657957;
27399884/00733132657957;
27399886/00733132657957;
27399894/00733132657964;
27399895/00733132657964;
27399896/00733132657964;
27399897/00733132657964;
27399898/00733132657964;
27399920/00733132657971;
27399921/00733132657971;
27399922/00733132657971;
27399923/00733132657971;
27399924/00733132657971;
27399925/00733132657971;
27399929/00733132657988;
27399933/00733132657988;
27399934/00733132657988;
27399935/00733132657988;
27399936/00733132657988;
27399937/00733132657988;
27399938/00733132657988;
27399939/00733132657988;
27399942/00733132657988;
27400054/00733132658015
27400056/ 00733132658015
27400073/ 00733132658022
27400077/ 00733132658039
27400078/ 00733132658039
27400079/ 00733132658039
27400084/ 00733132658039
27400085/ 00733132658039
27400103/ 00733132658046
27400104/ 00733132658046
27400105/ 00733132658046
27400110/ 00733132658046
27400111/ 00733132658046
27461768/ 00733132658046
27461769/ 00733132658046
|
Recalling Firm/
Manufacturer |
W L Gore & Associates, Inc.
3750 W Kiltie Ln
Flagstaff AZ 86005-8712
|
| For Additional Information Contact | Customer Care
800-528-8763 |
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Manufacturer Reason
for Recall | Due to packaging defects, sterility assurance and heparin activity may be compromised. |
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FDA Determined
Cause 2 | Package design/selection |
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| Action | 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. |
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| Quantity in Commerce | 100 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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