FDA Device recall Z-2693-2017
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to…
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to… 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-2693-2017 |
| 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
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. 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 | AAD255.1 AAN997.1 AAP279.1 AAP328.1 AAP333.1 AAT509.1 AAT579.1 AAT582.1 AAT652.1 AAT783.1 AAT792.1 AAT795.1…AAD255.1 AAN997.1 AAP279.1 AAP328.1 AAP333.1 AAT509.1 AAT579.1 AAT582.1 AAT652.1 AAT783.1 AAT792.1 AAT795.1 AAT797.1 AAT804.1 AAT845.1 AAT902.1 AAT976.1 AAT987.1 AAT989.1 AAU003.1 AAU009.1 AAU022.1 AAU046.1 AAU078.1 AAU094.1 ABA946.1 ABM329.1 ABM630.1 ABT798.1 ABT841.1 ACE689.1 ACE771.1 ACE786.1 ACE838.1 ACE875.1 ACE900.1 ACE936.1 ACE939.1 ACE994.1 ACF065.1 ACK145.1 ACK161.1 ACK241.1 ACK424.1 ACK511.1 ACK514.1 ACK549.1 ACK559.1 ACK622.1 ACK629.1 ACK637.1 ACK699.1 ACK702.1 ACK739.1 ACK752.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK855.1 ACP680.1 ACP686.1 ACP687.1 ACP700.1 ACP770.1 ACP780.1 ACP824.1 ACP833.1 ACP835.1 ACP869.1 ACP872.1 ACP874.1 ACP881.1 ACP883.1 ACT538.1 ACT548.1 ACT565.1 ACU349.1 ACU373.1 ACU381.1 ACU424.1 ADR679.1 ADR787.1 ADR794.1 ADR852.1 ADW762.1 ADW766.1 ADW771.1 AEH704.1 AEH733.1 AEH745.1 AEH748.1 AEH761.1 AEH764.1 AEH772.1 AEH826.1 AEH831.1 AEH856.1 AEH862.1 AEH865.1 |
|---|
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-2693-2017%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.