FDA Device recall Z-0022-2018
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667 by St Jude Medical, citing 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 e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0022-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-12 |
| Published | 2017-10-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
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.
Identifiers
| code_info | Serials implanted prior to September 12, 2017 are considered part of this advisory; Serial Numbers - AAD135.1 AAD136.…Serials implanted prior to September 12, 2017 are considered part of this advisory; Serial Numbers - AAD135.1 AAD136.1 AAD137.1 AAD138.1 AAD139.1 AAD140.1 AAD141.1 AAD144.1 AAD145.1 AAD146.1 AAD149.1 AAD152.1 AAD153.1 AAD154.1 AAD155.1 AAD157.1 AAD159.1 AAD161.1 AAD162.1 AAD163.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD172.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD189.1 AAD191.1 AAD192.1 AAD195.1 AAD196.1 AAD197.1 AAD198.1 AAD199.1 AAD200.1 AAD205.1 AAD206.1 AAD207.1 AAD209.1 AAD210.1 AAD211.1 AAD212.1 AAD214.1 AAD215.1 AAD217.1 AAD219.1 AAD221.1 AAD222.1 AAD223.1 AAD224.1 AAD225.1 AAD226.1 AAD228.1 AAD229.1 AAD230.1 AAD231.1 AAD232.1 AAD234.1 AAD235.1 AAD236.1 AAD237.1 AAD238.1 AAD239.1 AAD240.1 AAD241.1 AAD242.1 AAD246.1 AAD252.1 AAD259.1 AAD260.1 AAD263.1 AAD266.1 AAD267.1 AAD268.1 AAD269.1 AAD274.1 AAD275.1 AAD277.1 AAD278.1 AAD282.1 AAD284.1 AAD285.1 AAD286.1 AAD287.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0022-2018%22
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