FDA Device recall Z-0151-2023
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile
- FDA Device
- Class II
- ongoing
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile by Boston Scientific, citing there is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0151-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-30 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Reason
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Identifiers
| code_info | UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0151-2023%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.