FDA recall Z-0879-2021

Boston Scientific Corporation · Class I · device

Product

EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

Reason for recall

There is potential for fractures which results in the inability to delivery therapy.

Distribution

Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region

Key facts

Status
Terminated
Initiation date
2020-11-13
Report date
2021-01-27
Termination date
2024-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0879-2021