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U.S. Department of Health and Human Services

Class 1 Device Recall EMBLEM

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  Class 1 Device Recall EMBLEM see related information
Date Initiated by Firm November 13, 2020
Date Posted January 19, 2021
Recall Status1 Open3, Classified
Recall Number Z-0879-2021
Recall Event ID 87014
PMA Number P110042S077 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Code Information All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N Bldg 3
Saint Paul MN 55112-5700
For Additional Information Contact United States Technical Services
800-227-3422
Manufacturer Reason
for Recall		 There is potential for fractures which results in the inability to delivery therapy.
FDA Determined
Cause 2		 Device Design
Action Boston Scientific will communicate worldwide to physician customers via a customer letter. The firm notified consignees on December 2, 2020 via customer letter notifications (Dear Healthcare Professional, Dear Healthcare Administrator, and Dear Patient) . The customers notified will be as follows: " EMBLEM Electrode Model 3501 implanting physicians/centers and/or following physicians/centers of record for the advisory population. Physicians associated with an advisory device will receive a list of affected model/serials for patients which they have implanted and/or followed or sent to their center. " Centers/facilities with EMBLEM Subcutaneous Electrode Model 3501 inventory in stock. Boston Scientific will deliver the notification by hand or email via our sales representatives or deliver the letter via Federal Express, Courier, or email. Boston Scientific will reconcile that 100% of the identified customers /customer representatives signed for the letter, or the letter has been confirmed to be delivered. Boston Scientific will post the product advisory letter on our website, within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/productadvisories.html
Quantity in Commerce 47000 units
Distribution Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
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.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC CORPORATION
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