FDA recall Z-0935-2021

Product

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

Reason for recall

Accelerated battery depletion may result in a need for device replacement earlier than expected.

Distribution

worldwide

Key facts

Status

Ongoing

Initiation date

2020-12-02

Report date

2021-02-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0935-2021