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U.S. Department of Health and Human Services

Class 2 Device Recall EMBLEM MRI SICD Pulse Generator

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  Class 2 Device Recall EMBLEM MRI SICD Pulse Generator see related information
Date Initiated by Firm August 21, 2019
Create Date September 13, 2019
Recall Status1 Open3, Classified
Recall Number Z-2543-2019
Recall Event ID 83558
PMA Number P110042S058 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Code Information Model A219, Serial Number (Use Before Date) - 213636 (7/21/2019), 213637 (7/21/2019), 213638 (7/21/2019), 213639 (7/21/2019), 213640 (7/21/2019), 213641 (7/21/2019), 213642 (7/21/2019), 213643 (7/21/2019), 213644 (7/21/2019), 213645 (7/21/2019), 213646 (7/21/2019), 213647 (7/21/2019), 213648 (7/21/2019), 213649 (7/21/2019), 213650 (7/21/2019), 213651 (7/21/2019), 213652 (7/21/2019), 213653 (7/21/2019), 213654 (7/21/2019), 213655 (7/21/2019), 213656 (7/21/2019), 213657 (7/21/2019), 213658 (7/21/2019), 213659 (7/21/2019), 213660 (7/21/2019), 213661 (7/21/2019), 213662 (7/21/2019), 213663 (7/21/2019), 213665 (7/21/2019), 213666 (7/21/2019), 213667 (7/21/2019), 213668 (7/21/2019), 213669 (7/21/2019), 213670 (7/21/2019), 213671 (7/21/2019), 213672 (7/21/2019), 213673 (7/21/2019), 213674 (7/21/2019), 213675 (7/21/2019), 213676 (7/21/2019), 213677 (7/21/2019), 213678 (7/21/2019), 213679 (7/21/2019), 213680 (7/21/2019), 213681 (7/21/2019), 213682 (7/21/2019), 213683 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Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N Bldg 3
Saint Paul MN 55112-5700
For Additional Information Contact
800-227-3422
Manufacturer Reason
for Recall		 Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
FDA Determined
Cause 2		 Component design/selection
Action Boston Scientific began notifying physicians of the recall on about 08/21/2019, via "URGENT: MEDICAL DEVICE ADVISORY" letter. The physicians associated with the affected devices were provide a letter with a list of affected model/serial numbers for patients which they have implanted and/or followed or sent to their center. The letter informed physicians of the potential for accelerated battery depletion on select active worldwide EMBLEM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs). Physicians were instructed to follow up with affected units implanted in patients by enroll and monitoring patients in LATITUDE to facilitate prompt detection of ERI/EOL during the interval between in-office device checks, perform a device follow-up every 3 months via remote or in-office interrogation, promptly investigate any suspected indication of accelerated depletion and contact Boston Scientific Technical Services for assistance as needed, and append the patients medical record with this letter to maintain awareness of this topic for the remaining service life of the device. Physicians were also instructed to evaluate the potential for life-threatening harm due to accelerated depletion for patients are the greatest risk, and replace the affected device within 21 days of ERI and prophylactically for those devices in high risk patients. Boston Scientific also provided an advisory letter for all EMBLEM physicians in order to reiterate and summarize the battery management recommendations that exist in current EMBLEM S-ICD labeling. Included in the customer notification to each physician was (affected and advisory) is a patient advisory letter, which each physician can chose at their discretion to provide. Questions and comments for US customers can be directed to Technical Services, Phone: 1.800.CARDIAC (227.3422) or Email: tech.services@bsci.com. In addition, Boston Scientific worked with the Heart Rhythm Society who sent an email August 22, 20
Quantity in Commerce 404 devices
Distribution Nationwide distribution to Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin, Wyoming. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, , Lithuania, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. - Virgin Islands, United Arab Emirates, 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.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC CORPORATION
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