FDA Device recall Z-0879-2021
EMBLEM S-ICD Subcutaneous Electrode Model 3501
- FDA Device
- Class I
- terminated
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class I recall of EMBLEM S-ICD Subcutaneous Electrode Model 3501 by Boston Scientific, citing there is potential for fractures which results in the inability to delivery therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0879-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-11-13 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Reason
There is potential for fractures which results in the inability to delivery therapy.
Identifiers
| code_info | All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0879-2021%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.