St. Jude Medical, Inc.: 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.

Recall number

Z-2693-2017

Recalling firm

St. Jude Medical, Inc.

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.

Status

Terminated

Initiated

2017-06-02

Posted

not on file

Terminated

2022-08-24

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.

Root cause

Device Design

Action

The notification material is in the form of a Physician Letter and Patient letter which will be delivered to physicians and patients in the US. The physician mailing will be initiated June 2, 2017 for delivery on June 7-9, 2017. The physicians were provided with patient management recommendations, Step for the patient controller updates, and Clinician's Manual Revised Warning. The Patient mailings will begin the week of June 12, 2017 to allow for clinician notification and are expected to be delivered within 3-5 business days. The patient letter informs of them of the potential for the loss of therapy and the steps to receive the software upgrade.

Quantity

443 units

Distribution

US Nationwide Distribution

Lot, serial or model codes

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 AEH883.1 AEH951.1 AEH953.1 AEH955.1 AEH962.1 AEH972.1 AEJ054.1 AEJ100.1 AEJ101.1 AEJ106.1 AEJ111.1 AEJ145.1 AEJ148.1 AEJ164.1 AEJ167.1 AEJ203.1 AEJ241.1 AEJ251.1 AEJ252.1 AEJ257.1 AEM803.1 AEM833.1 AEM852.1 AEM857.1 AEM877.1 AEM885.1 AEM887.1 AEM888.1 AEM917.1 AEM951.1 AEM964.1 AEM967.1 AEM969.1 AEM988.1 AFB225.1 AFB349.1 AFB376.1 AFB425.1 AFB433.1 AFB434.1 AFB436.1 AFB444.1 AFB454.1 AFB495.1 AFB658.1 AFG344.1 AFG446.1 AFG471.1 AFG496.1 AFG545.1 AFG668.1 AFG672.1 AFG679.1 AFG704.1 AFG724.1 AFG947.1 AFG959.1 AFZ174.1 AFZ211.1 AFZ224.1 AFZ260.1 AFZ359.1 AFZ364.1 AFZ384.1 AFZ409.1 AFZ427.1 AFZ532.1 AFZ588.1 AFZ590.1 AFZ807.1 AFZ835.1 AFZ851.1 AFZ996.1 AGM602.1 AGM732.1 AGM765.1 AGM950.1 AGN231.1 AGN324.1 AGN447.1 AGN490.1 AGN552.1 AGN616.1 AHD572.1 AHD578.1 AHD589.1 AHD612.1 AHD646.1 AHD648.1 AHD663.1 AHD677.1 AHD686.1 AHD713.1 AHD818.1 AHD821.1 AHD822.1 AHK567.1 AHK727.1 AHK778.1 AHK897.1 AHK906.1 AHK922.1 AHK976.1 AHL049.1 AHL054.1 AHL069.1 AHL093.1 AHL095.1 AHL097.1 AHL105.1 AHL122.1 AHL133.1 AHL135.1 AHL138.1 AHL195.1 AHV557.1 AHV591.1 AHV603.1 AHV679.1 AHV705.1 AHV797.1 AHV801.1 AHV802.1 AHV807.1 AHV810.1 AHV818.1 AHV824.1 AHV843.1 AHV851.1 AHV854.1 AHV855.1 AHV860.1 AHV873.1 AHV921.1 AHV937.1 AHV945.1 AHV947.1 AHV965.1 AHV971.1 AHV975.1 AHV992.1 AHW028.1 AHW049.1 AHW055.1 AHW080.1 AHW082.1 AHW085.1 AHW104.1 AHW156.1 AHW489.1 AHW492.1 AHW496.1 AHW498.1 AHW661.1 AHW663.1 AHW670.1 AHW683.1 AJP994.1 AJP995.1 AJR053.1 AJR058.1 AJR073.1 AJR075.1 AJR076.1 AJR077.1 AJW280.1 AJW285.1 AJW287.1 AJW290.1 AJW296.1 AJW310.1 AJW328.1 AJW329.1 AJW334.1 AJW336.1 AJW345.1 AJW365.1 AJW382.1 AJW384.1 AJW388.1 AJW393.1 AJW412.1 AJW422.1 AJW431.1 AJW461.1 AJW487.1 AKX628.1 ALE668.1 ALE944.1 ALJ257.1 ALJ402.1 ALJ928.1 ALJ984.1 ALJ992.1 ALN367.1 ALN378.1 ALN429.1 ALN438.1 ALN441.1 ALN444.1 ALN448.1 ALN451.1 ALN469.1 ALN477.1 ALN487.1 ALN547.1 ALN593.1 ALN596.1 ALN622.1 ALN628.1 ALN634.1 ALN658.1 ALX037.1 ALX043.1 ALX053.1 ALX085.1 ALX203.1 ALX313.1 ALY252.1 ALY270.1 ALY272.1 ALY313.1 ALY329.1 ALY367.1 ALY369.1 ALY371.1 ALY400.1 ALY431.1 ALY533.1 ALY544.1 ALY610.1 ALY624.1 ALY625.1 ALY636.1 ALY653.1 ALY660.1 ALY774.1 ALY778.1 ALY799.1 ALY801.1 ALY802.1 ALY810.1 ALZ039.1 ALZ051.1 ALZ064.1 ALZ080.1 ALZ311.1 AMK053.1 AMN786.1 AMN963.1 AMP153.1 AMP226.1 AMS002.1 AMS004.1 AMS007.1 AMS022.1 AMS024.1 AMS026.1 AMS038.1 AMS068.1 AMS073.1 AMS126.1 AMS127.1 AMS161.1 AMS169.1 AMS193.1 AMS228.1 AMS241.1 AMS248.1 AMS256.1 AMS258.1 AMS259.1 AMS270.1 AMS271.1 AMS400.1 AMS431.1 AMS879.1 AMT051.1 AMT260.1 AMT351.1 ANG969.1 ANG990.1 ANH036.1 ANH126.1 ANH170.1 ANH185.1 ANH258.1 ANH278.1 ANH468.1 ANH503.1 ANH603.1 ANH618.1 ANH636.1 ANL856.1 YY2921.1 YY5780.1 YY5876.1 YY6049.1 YY6118.1 YZ1385.1 YZ1487.1 YZ1509.1 YZ1511.1 YZ1514.1 YZ1515.1 YZ1531.1 YZ1574.1 YZ1595.1 YZ9624.1 YZ9636.1 YZ9648.1 YZ9651.1 YZ9654.1 YZ9683.1 YZ9691.1 YZ9702.1 YZ9709.1 YZ9712.1 YZ9713.1 YZ9724.1 YZ9732.1 YZ9749.1 YZ9755.1 YZ9768.1 YZ9826.1 YZ9857.1 ZK3232.1 ZK3240.1 ZK3253.1 ZK3370.1 ZV3919.1 ZW0254.1 ZW0302.1 ZW0587.1 ZW8865.1 ZW8885.1 ZW8943.1 ZW8991.1 ZY8811.1 ZY8821.1 ZY9321.1 ZY9369.1 ZY9406.1

510(k) numbers

not on file

PMA numbers

["P140009"]

Product code

MHY

Firm FEI

1627487

Firm city

Plano

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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