W L Gore & Associates, Inc.: 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.

Recall number

Z-2946-2024

Recalling firm

W L Gore & Associates, Inc.

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.

Status

Open, Classified

Initiated

2024-07-01

Posted

2024-08-30

Terminated

not on file

Reason

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

Root cause

Package design/selection

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.

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

PRL

Firm FEI

2017233

Firm city

Flagstaff

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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