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

Recall Insight

This FDA Devices action (record #Z-2542-2019) was formally reported on September 25, 2019, with the manufacturer initiating the action on August 21, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Boston Scientific Corporation is listed as the recalling firm, operating out of Saint Paul, MN. Federal records indicate 28 devices units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide distribution to Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Ne…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.