FDA recall Z-0034-2018

Product

PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2017-08-28

Report date

2017-10-25

Termination date

2020-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sylmar, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0034-2018