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St. Jude Medical, Inc. recalls Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3
Recalled October 25, 2017 · FDA recall Z-0022-2018 · St. Jude Medical
Hazard
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. · FDA Class II
Units
28,817 devices
Sold at
Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)
Description
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.
Product
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Manufacturer(s)
St. Jude Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →