St. Jude Medical, Inc. recalls Proclaim DRG Implantable Pulse Generator Model 3664

Recall date

September 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0024-2018

FDA classification

Class II

Brand / firm

St. Jude Medical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Proclaim DRG Implantable Pulse Generator Model 3664