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U.S. Department of Health and Human Services

Class 2 Device Recall EkoSonic Endovascular Device

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  Class 2 Device Recall EkoSonic Endovascular Device see related information
Date Initiated by Firm May 25, 2022
Create Date August 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1491-2022
Recall Event ID 90528
510(K)Number K213422  
Product Classification Mechanical thrombolysis catheter - Product Code QEY
Product EkoSonic Kit 135cm, 12cm TZ

The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Code Information UPN: 500-56112  GTIN: 858593006264  Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Rebecca KinKead Rubio
763-494-1133
Manufacturer Reason
for Recall		 Product may be mislabeled.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm notified affected consignees by telephone beginning May 25, 2022 to inform them of the potential of improperly packaged devices. On May 26, 2022, customer notifications, including a letter, instructions and reply form) were sent to all affected accounts via FedEx Overnight Delivery. Consignees are asked to return any affected and unused devices to BSC. The field removal letter will provide customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form (RVTF) indicating they have received the field removal and followed the included instructions.
Quantity in Commerce 10 units
Distribution US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QEY and Original Applicant = Boston Scientific Corporation
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