Class 2 Device Recall EMBLEM SICD

• Date Initiated by Firm: September 30, 2022
• Date Posted: October 31, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0152-2023
• Recall Event ID: 90985
• PMA Number: P110042
• Product Classification: Permanent defibrillator electrodes - Product Code NVY
• Product: EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
• Code Information: UPN: 00802526584404, Serial numbers: 169280, 169298, 169494, 169753, 169776, 169934, 169941, 170003, 169547, 169151, 169315, 169514, 169851, 169879, 169292, 169696, 169786, 169788, 169852, 170002, 169400, 169405, 169898, 169973, 169885, 169335, 169233, 169608, 169304, 169410, 166452, 169278, 169319, 169321, 169651, 169688, 169864, 169920, 169235, 169277, 169834, 169472, 169417, 169202, 169329, 169426, 169511, 169529, 169630, 169757, 169963, 167092, 169236, 169301, 169310, 169316, 169393, 169436, 169485, 169537, 169543, 169565, 169567, 169571, 169579, 169582, 169599, 169601, 169606, 169663, 169771, 169238, 169323, 169680, 169270, 169265, 169372. UPN: 00802526581519, Serial numbers 169312, 169409, 169421, 169428, 169521, 169561, 169493, 169654, 169653, 169635, 169731, 169477, 169495, 169496, 169474, 169491, 169468, 169455, 169442, 169446, 169435, 169447, 168979, 169271, 169384, 169353, 169371, 169351, 169203, 169469, 169471, 169314, 169342, 169475, 169448, 169404, 169407, 169450, 169396, 169470, 169356, 169373, 169402, 169413, 169441, 169539, 169545, 169551, 169674, 169267, 169350, 169589, 169307, 169595, 169596, 169600, 169286, 169603, 169605, 169206, 169340, 169502, 169505, 169510, 169348.
• FEI Number: 2124215
• 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 an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm emailed Dear Health Care Professional or Hospital Administrator retrieval letters dated 9/30/2022 to their sales representatives on 9/30/2022 who began hand delivering them immediately in the U.S. for delivery to those consignees who were believed to have unimplanted devices in their possession. The letter described the issue and said their Boston Scientific sales representative is available to support this retrieval and listed the following steps to be taken: (1) Immediately segregate all affected product listed in Appendix A of the letter to ensure it will not be used; (2) Complete the attached Reply Verification Tracking Form and return it via the email address provided or via FAX; and (3) Ship product back to Boston Scientific, and the address was provided. OUS notification began 10/3/2022. For the U.S. patients who have already been implanted with the device, correction letters are to be hand-delivered to the doctors the week of 10/17/2022 and the sales representatives will send confirmation of delivery back to the recalling firm. No reply form was enclosed with the correction letter. These letters will be personalized/customized with the name of the following or implanting physicians or clinics. The letters will be dated October 2022 and contain the patient's name, date of birth, and the model/serial number and GTIN implanted. The letter will describe the issue, clinical impact, and recommendations regarding follow-up interval, patient notes entry, and medial records. Prophylactic replacement is not recommended as the issue does not affect the S-ICDs performance or the actual battery longevity.
• Quantity in Commerce: 142 devices
• Distribution: Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.
• 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.