FDA Device recall Z-2542-2019
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
- FDA Device
- Class II
- ongoing
- Published 2019-09-25
On 2019-09-25 the FDA classified a Class II recall of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2542-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-08-21 |
| Published | 2019-09-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
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.
Identifiers
| code_info | Model A209, Serial Number (Use Before Date) - 213729 (7/24/2019), 213859 (7/26/2019), 213891 (7/27/2019), 213896 (7/27/…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); |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2542-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.