Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Contego Medical, Inc
The hazard
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model REF/UDI-DI/Lot: NG-0630-140-2/00851616007583/Z2460578DModel Z2460740BModel Z2460872CModel Z2460909FModel Z2460948DModel Z2460957QModel NG-0640-140-2/00851616007590/Z2460578EModel Z2460647SModel Z2460706AModel Z2460746CModel Z2460774AModel Z2460865CModel Z2460872BModel Z2460901BModel Z2460909DModel Z2460909KModel Z2460945HModel Z2460948IModel Z2460963NModel NG-0730-140-2/00851616007606/Z2460578FModel Z2460662AModel Z2460740AModel Z2460774FModel Z2460850AModel Z2460900BUPC 00851616007583UPC 00851616007590UPC 00851616007606UPC 00851616007613UPC 00851616007644UPC 00851616007651UPC 00851616007637UPC 00851616007620Would you have heard about this one?
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