Boston Scientific Corporation: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

Recall number

Z-2542-2019

Recalling firm

Boston Scientific Corporation

Product

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

Status

Open, Classified

Initiated

2019-08-21

Posted

not on file

Terminated

not on file

Reason

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.

Root cause

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

28 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.

Lot, serial or model codes

Model A209, Serial Number (Use Before Date) - 213729 (7/24/2019), 213859 (7/26/2019), 213891 (7/27/2019), 213896 (7/27/2019), 213898 (7/27/2019), 213901 (7/27/2019), 213902 (7/27/2019), 213904 (7/27/2019), 213910 (7/27/2019), 213919 (7/27/2019), 213921 (7/27/2019), 213937 (7/27/2019), 213938 (7/27/2019), 213943 (7/27/2019), 213946 (7/27/2019), 213961 (7/28/2019), 213972 (7/28/2019), 213975 (7/28/2019), 213976 (7/28/2019), 213979 (7/28/2019), 213982 (7/28/2019), 213983 (7/28/2019), 214020 (7/31/2019), 214030 (7/31/2019), 214032 (7/31/2019), 214036 (7/31/2019), 214042 (7/31/2019), 214083 (7/31/2019);

510(k) numbers

not on file

PMA numbers

["P110042S043"]

Product code

LWS

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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