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Boston Scientific Corporation Recall 87839

Description: ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion lengths up to 190 mm.

Boston Scientific Corporation Recall 87839 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1621-2021
Event ID87839
Event DescriptionELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion lengths up to 190 mm.
Product TypeDevices
DistributionUS Nationwide distribution in the states of AL, AR, AZ, CA, DE, HI, IL, KS, KY, MA, MD, NC, NJ, NV, NY, OH, OK, PA,PR, TX, VA,WA,WV.
Quantity27 UNITS
Recall ReasonOne batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Device Classification20210526
Device Code InfoLOT: 25838357
Center Classification Date20210518
Recall Initiation Date20210421
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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