- Recalling firm
- Contego Medical, Inc
- Reason for recall
- Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
- Affected products (lot / model / serial)
- REF/UDI-DI/Lot: NG-0630-140-2/00851616007583/Z2460578D,Z2460740B, Z2460872C, Z2460909F, Z2460948D, Z2460957Q; NG-0640-140-2/00851616007590/Z2460578E, Z2460647S, Z2460706A, Z2460746C, Z2460774A, Z2460865C, Z2460872B, Z2460901B, Z2460909D, Z2460909K, Z2460945H, Z2460948I, Z2460963N; NG-0730-140-2/00851616007606/Z2460578F, Z2460662A, Z2460740A , Z2460774F, Z2460850A, Z2460900B, Z2460945F, Z2460957R; NG-0740-140-2/00851616007613/Z2460578G, Z2460635C, Z2460656A, Z2460707D, Z2460733A, Z2460766A, Z2460774B, Z2460780A , Z2460865A, Z2460871A, Z2460872D, Z2460900D, Z2460909B, Z2460909I, Z2460948F, Z2460963T; NG-NV-6-30/00851616007644/Z2460776A, Z2460893A, Z2460909G, Z2460948E; NG-NV-6-40/00851616007651/Z2460776B, Z2460865D, Z2460865E, Z2460901C, Z2460909E, Z2460909J, Z2460957P, Z2460963K, Z2460963P; NG-NV-7-30/00851616007637/Z2460776C, Z2460789H, Z2460850B, Z2460900C, Z2460916A, Z2460948H, Z2460998A; NG-NV-7-40/00851616007620/Z2460776D, Z2460878A, Z2460872A, Z2460872E, Z2460901A, Z2460909C, Z2460909H, Z2460945G, Z2460948G, Z2460966B, Z2460963J;
- Units affected
- 5069
- Distribution pattern
- US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.
- Firm location
- Raleigh, NC, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2911-2026
- Recall initiated
- June 29, 2026
- FDA classification date
- August 6, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99353
- Last updated on HTM Vibe
- August 18, 2026