{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Plano", "state": "TX", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "77509", "recalling_firm": "St. Jude Medical, Inc.", "address_1": "6901 Preston Rd", "address_2": "", "postal_code": "75024-2508", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-2693-2017", "product_description": "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.", "product_quantity": "443 units", "reason_for_recall": "The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.", "recall_initiation_date": "20170602", "center_classification_date": "20170707", "termination_date": "20220824", "report_date": "20170719", "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 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", "more_code_info": "" } ] }