Recall Z-0022-2018— St. Jude Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by St. Jude Medical, Inc., initiated 2017-09-12, terminated 2020-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667. Reason: 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..
- Recalling firm
- St. Jude Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-12
- Terminated
- 2020-04-16
- Firm location
- Plano, TX, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.