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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Emblem

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  Class 2 Device Recall Boston Scientific Emblem see related information
Date Initiated by Firm July 11, 2023
Date Posted August 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-2441-2023
Recall Event ID 92760
PMA Number P110042 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Code Information GTIN: 00802526544101, 00802526548406, 00802526575105, 00802526575112, 00802526575129, 00802526575136, 00802526575143, 00802526575167, 00802526575181, 00802526575204, 00802526575211, 00802526575228, 00802526599002; All EMBLEM S-ICDs enrolled in LATITUDE
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact United States Technical Services
800-227-3422
Manufacturer Reason
for Recall		 There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
FDA Determined
Cause 2		 Software design
Action Boston Scientific disseminated an Important Medical Device Information notice to the physician or healthcare professional consignees beginning on 07/11/2023 by hand delivery using their sales representatives, The notices explain the problem, risk, and recommend the following: Please distribute this letter to all HCPs who manage follow-ups of S-ICD patients. Perform the next scheduled device check in-person using a Model 3300 LATITUDE programmer with Model 3877 v1.04 software or Model 3200 EMBLEM programmer with Model 2877 v4.10 software to address any potential for this rare S-ICD behavior. Up-to-date product performance information and a device lookup tool are available within our Product Performance Resource Center at www.bostonscientific.com/ppr. If you have additional questions regarding this information or need to report an adverse event, please contact your Boston Scientific representative or Technical Services, and your local regulatory authority, as applicable. On 08/16/2023 Boston Scientific mailed the letter to EMBLEM S-ICD implanting and/or following physicians/clinics of record. On 09/15/2023, Boston Scientific began distributing a letter dated September 2023 (with the original communication enclosed), to new implanting and following physicians/clinics of record since the August 2023 communication.
Quantity in Commerce 3,856 units
Distribution Worldwide
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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