Z-1621-2021 Class II Terminated
FDA device recall Z-1621-2021 was initiated by Boston Scientific Corporation on April 21, 2021 and is designated Class II. Reason for recall: One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging. The recall status is terminated (terminated August 7, 2023). Affected quantity: 27 UNITS.
Recall Details
- Product Type
- Devices
- Report Date
- May 26, 2021
- Initiation Date
- April 21, 2021
- Termination Date
- August 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 UNITS
Product 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.
Reason for Recall
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Distribution Pattern
US 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.
Code Information
LOT: 25838357