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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 December 02, 2020
Date Posted February 05, 2021
Recall Status1 Terminated 3 on June 23, 2022
Recall Number Z-0951-2021
Recall Event ID 86902
PMA Number P110042S043 P110042S058 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product EMBLEM MRI S-ICD Model A219
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219923, 219952
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		 Electrical overstress may lead to device malfunction.
FDA Determined
Cause 2		 Process control
Action Boston Scientific will communicate worldwide to physician customers via a customer letter. The customers notified will be as follows: " EMBLEM S-ICD 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. 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 872 units
Distribution Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
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.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC CORPORATION
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