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U.S. Department of Health and Human Services

Class 2 Device Recall ELUVIA

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  Class 2 Device Recall ELUVIA see related information
Date Initiated by Firm April 21, 2021
Create Date May 18, 2021
Recall Status1 Terminated 3 on August 07, 2023
Recall Number Z-1621-2021
Recall Event ID 87839
Product Classification Stent, superficial femoral artery, drug-eluting - Product Code NIU
Product 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.
Code Information LOT: 25838357
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Rebecca KinKead Rubio
763-494-1700
Manufacturer Reason
for Recall		 One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
FDA Determined
Cause 2		 Reprocessing Controls
Action On April 21, 2021 the firm sent a letter to its customers with Immediate Action Required with the following instructions: If you identify any product from the listed batch within your inventory, please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed instructions. You will receive replacement product for all removed product returned to Boston Scientific. If you are a distributor, please note that the removal depth is to the hospital level and the removal notification should be forwarded to your customers.
Quantity in Commerce 27 UNITS
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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