Z-2542-2019Class II

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

Name: Z-2542-2019 Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Creator: Boston Scientific Corporation
Published: 2019-08-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-08-21 / Open, Classified / root cause: design

FDA source

Boston Scientific Corporation began a recall of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator on 2019-08-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2542-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-21
Posted: 2019-09-13
Recalling firm: Boston Scientific Corporation
Product: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: design
FDA 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: [email protected]. In addition, Boston Scientific worked with the Heart Rhythm Society who sent an email August 22, 20
Quantity in commerce: 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.
Product codes and lots: 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);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2542-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2542-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-09-25	2019-09-13
Z-2543-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-09-25	2019-09-13

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)