FDA recall Z-0080-2018

Product

MOMENTUM X4 CRT-D, Model G138, Sterile.

Reason for recall

The devices have an incorrect firmware configuration.

Distribution

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

Key facts

Status

Terminated

Initiation date

2017-10-04

Report date

2017-11-15

Termination date

2019-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2018