FDA recall Z-0022-2018

Product

Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667

Reason for recall

Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.

Distribution

Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)

Key facts

Status

Terminated

Initiation date

2017-09-12

Report date

2017-10-25

Termination date

2020-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plano, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0022-2018