FDA Device recall Z-2691-2017
Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG)…
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG)… by St Jude Medical, citing the firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2691-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-02 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
Reason
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Identifiers
| code_info | AAD154.1 AAD159.1 AAD161.1 AAD172.1 AAD188.1 AAD197.1 AAD199.1 AAD200.1 AAD206.1 AAD211.1 AAD214.1 AAD219.1…AAD154.1 AAD159.1 AAD161.1 AAD172.1 AAD188.1 AAD197.1 AAD199.1 AAD200.1 AAD206.1 AAD211.1 AAD214.1 AAD219.1 AAD222.1 AAD230.1 AAD232.1 AAD235.1 AAD240.1 AAD241.1 AAD246.1 AAD248.1 AAD252.1 AAD260.1 AAD268.1 AAD269.1 AAD274.1 AAD282.1 AAD284.1 AAD286.1 AAD291.1 AAD292.1 AAD303.1 AAD304.1 AAD305.1 AAD306.1 AAD311.1 AAD312.1 AAD317.1 AAD321.1 AAD334.1 AAD341.1 AAD343.1 AAD358.1 AAD361.1 AAD363.1 AAD364.1 AAD366.1 AAD369.1 AAD370.1 AAD374.1 AAD378.1 AAD382.1 AAN928.1 AAN929.1 AAN930.1 AAN931.1 AAN932.1 AAN935.1 AAN937.1 AAN942.1 AAN945.1 AAN949.1 AAN950.1 AAN956.1 AAN961.1 AAN966.1 AAN967.1 AAN972.1 AAN978.1 AAN979.1 AAN983.1 AAN985.1 AAN986.1 AAN992.1 AAN994.1 AAN999.1 AAP002.1 AAP003.1 AAP012.1 AAP021.1 AAP027.1 AAP037.1 AAP041.1 AAP042.1 AAP051.1 AAP058.1 AAP064.1 AAP065.1 AAP068.1 AAP071.1 AAP073.1 AAP074.1 AAP084.1 AAP086.1 AAP087.1 AAP091.1 AAP098.1 AAP101.1 AAP105.1 AAP110.1 AAP112.1 |
|---|
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-2691-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.