Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

What Should You Do?

1. Check if you have this product:
   Serials implanted prior to September 12, 2017 are considered part of this advisory; Serial Numbers - AAD193.1 AAD194.1 AAD213.1 AAD255.1 AAD257.1 AAD261.1 AAD276.1 AAD279.1 AAD281.1 AAD298.1 AAD299.1 AAD302.1 AAD309.1 AAD328.1 AAD372.1 AAD376.1 AAD380.1 AAN940.1 AAN946.1 AAN951.1 AAN977.1 AAN997.1 AAP006.1 AAP007.1 AAP030.1 AAP035.1 AAP108.1 AAP132.1 AAP140.1 AAP149.1 AAP193.1 AAP217.1 AAP266.1 AAP273.1 AAP279.1 AAP293.1 AAP314.1 AAP328.1 AAP333.1 AAP362.1 AAP363.1 AAP375.1 AAP376.1 AAP385.1 AAP387.1 AAP409.1 AAP410.1 AAT509.1 AAT540.1 AAT571.1 AAT572.1 AAT577.1 AAT579.1 AAT582.1 AAT626.1 AAT634.1 AAT652.1 AAT657.1 AAT660.1 AAT722.1 AAT754.1 AAT772.1 AAT774.1 AAT776.1 AAT783.1 AAT792.1 AAT795.1 AAT797.1 AAT804.1 AAT805.1 AAT830.1 AAT841.1 AAT845.1 AAT849.1 AAT870.1 AAT873.1 AAT885.1 AAT890.1 AAT891.1 AAT899.1 AAT902.1 AAT910.1 AAT976.1 AAT987.1 AAT989.1 AAT990.1 AAT994.1 AAU003.1 AAU009.1 AAU022.1 AAU029.1 AAU031.1 AAU046.1 AAU047.1 AAU056.1 AAU068.1 AAU071.1 AAU084.1 AAU094.1 AAU095.1 AAU096.1 AAU148.1 ABA946.1 ABA964.1 ABA995.1 ABB011.1 ABB022.1 ABB051.1 ABB128.1 ABJ141.1 ABJ142.1 ABJ148.1 ABJ155.1 ABJ156.1 ABJ165.1 ABJ175.1 ABJ177.1 ABJ186.1 ABJ196.1 ABJ197.1 ABJ234.1 ABJ242.1 ABJ243.1 ABJ255.1 ABJ282.1 ABJ284.1 ABJ285.1 ABJ295.1 ABJ311.1 ABJ313.1 ABJ315.1 ABJ321.1 ABJ328.1 ABJ349.1 ABJ386.1 ABJ388.1 ABJ390.1 ABJ392.1 ABJ411.1 ABJ444.1 ABJ445.1 ABJ448.1 ABJ449.1 ABJ458.1 ABJ472.1 ABJ485.1 ABJ501.1 ABJ503.1 ABJ504.1 ABJ505.1 ABJ506.1 ABJ526.1 ABJ556.1 ABJ614.1 ABM287.1 ABM308.1 ABM310.1 ABM312.1 ABM313.1 ABM329.1 ABM334.1 ABM381.1 ABM408.1 ABM459.1 ABM471.1 ABM472.1 ABM540.1 ABM541.1 ABM581.1 ABM589.1 ABM592.1 ABM593.1 ABM620.1 ABM630.1 ABM651.1 ABT714.1 ABT728.1 ABT739.1 ABT740.1 ABT745.1 ABT785.1 ABT798.1 ABT800.1 ABT811.1 ABT829.1 ABT832.1 ABT839.1 ABT841.1 ABT844.1 ABT883.1 ABT892.1 ABT900.1 ABT948.1 ABT956.1 ABT967.1 ABT975.1 ABT981.1 ABT984.1 ABT990.1 ABT991.1 ABU014.1 ABU018.1 ABU024.1 ABU036.1 ABU058.1 ABU061.1 ABU079.1 ABU099.1 ABU107.1 ABU119.1 ABU146.1 ABU164.1 ABU183.1 ACD615.1 ACD617.1 ACD652.1 ACD655.1 ACD656.1 ACD682.1 ACD686.1 ACD721.1 ACD768.1 ACD772.1 ACD773.1 ACD797.1 ACD800.1 ACD802.1 ACD812.1 ACD849.1 ACE661.1 ACE669.1 ACE689.1 ACE699.1 ACE740.1 ACE771.1 ACE772.1 ACE780.1 ACE786.1 ACE838.1 ACE843.1 ACE860.1 ACE868.1 ACE875.1 ACE877.1 ACE892.1 ACE900.1 ACE912.1 ACE917.1 ACE922.1 ACE936.1 ACE939.1 ACE942.1 ACE947.1 ACE994.1 ACF006.1 ACF039.1 ACF048.1 ACF065.1 ACK135.1 ACK136.1 ACK140.1 ACK145.1 ACK159.1 ACK161.1 ACK165.1 ACK200.1 ACK224.1 ACK228.1 ACK231.1 ACK241.1 ACK253.1 ACK269.1 ACK286.1 ACK289.1 ACK318.1 ACK325.1 ACK379.1 ACK385.1 ACK424.1 ACK428.1 ACK429.1 ACK431.1 ACK448.1 ACK457.1 ACK500.1 ACK511.1 ACK514.1 ACK525.1 ACK526.1 ACK549.1 ACK554.1 ACK559.1 ACK581.1 ACK583.1 ACK592.1 ACK594.1 ACK602.1 ACK615.1 ACK622.1 ACK629.1 ACK632.1 ACK634.1 ACK637.1 ACK674.1 ACK677.1 ACK699.1 ACK702.1 ACK705.1 ACK706.1 ACK709.1 ACK719.1 ACK739.1 ACK742.1 ACK744.1 ACK752.1 ACK757.1 ACK759.1 ACK760.1 ACK762.1 ACK775.1 ACK776.1 ACK778.1 ACK783.1 ACK784.1 ACK786.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK837.1 ACK841.1 ACK844.1 ACK846.1 ACK855.1 ACK872.1 ACP669.1 ACP670.1 ACP675.1 ACP676.1 ACP680.1 ACP684.1 ACP685.1 ACP686.1 ACP687.1 ACP690.1 ACP695.1 ACP700.1 ACP737.1 ACP756.1 ACP767.1 ACP769.1 ACP770.1 ACP775.1 ACP777.1 ACP780.1 ACP783.1 ACP797.1 ACP804.1 ACP820.1 ACP824.1 ACP827.1 ACP829.1 ACP833.1 ACP835.1 ACP836.1 ACP862.1 ACP866.1 ACP869.1 ACP872.1 ACP874.1 ACP881.1 ACP883.1 ACP885.1 ACP890.1 ACP893.1 ACP909.1 ACP915.1 ACT538.1 ACT542.1 ACT547.1 ACT548.1 ACT555.1 ACT556.1 ACT558.1 ACT562.1 ACT563.1 ACT565.1 ACT580.1 ACT582.1 ACT589.1 ACT590.1 ACT591.1 ACT595.1 ACT632.1 ACT645.1 ACT654.1 ACT684.1 ACT708.1 ACT737.1 ACT754.1 ACT756.1 ACT855.1 ACT869.1 ACT884.1 ACT895.1 ACU006.1 ACU060.1 ACU081.1 ACU085.1 ACU091.1 ACU117.1 ACU147.1 ACU158.1 ACU165.1 ACU193.1 ACU194.1 ACU198.1 ACU216.1 ACU220.1 ACU247.1 ACU267.1 ACU272.1 ACU342.1 ACU349.1 ACU358.1 ACU373.1 ACU374.1 ACU381.1 ACU390.1 ACU404.1 ACU424.1 ADD433.1 ADD484.1 ADD587.1 ADD593.1 ADD633.1 ADD634.1 ADD635.1 ADD645.1 ADD647.1 ADD654.1 ADD668.1 ADD673.1 ADD681.1 ADD729.1 ADD730.1 ADD731.1 ADD733.1 ADD739.1 ADD744.1 ADD754.1 ADD765.1 ADD768.1 ADD786.1 ADD792.1 ADD808.1 ADD897.1 ADD899.1 ADD904.1 ADD905.1 ADD910.1 ADD915.1 ADD922.1 ADD946.1 ADD947.1 ADD949.1 ADD956.1 ADD970.1 ADD971.1 ADD976.1 ADD985.1 ADD986.1 ADD995.1 ADE002.1 ADE014.1 ADE027.1 ADE030.1 ADE040.1 ADE073.1 ADE100.1 ADE104.1 ADE105.1 ADE127.1 ADE129.1 ADE144.1 ADE152.1 ADJ715.1 ADJ719.1 ADJ747.1 ADK131.1 ADK151.1 ADK216.1 ADK261.1 ADK277.1 ADN219.1 ADN238.1 ADN241.1 ADN246.1 ADN303.1 ADN388.1 ADN390.1 ADR252.1 ADR283.1 ADR292.1 ADR293.1 ADR296.1 ADR309.1 ADR337.1 ADR340.1 ADR349.1 ADR353.1 ADR355.1 ADR369.1 ADR377.1 ADR392.1 ADR399.1 ADR417.1 ADR432.1 ADR435.1 ADR451.1 ADR452.1 ADR467.1 ADR480.1 ADR512.1 ADR521.1 ADR522.1 ADR539.1 ADR545.1 ADR549.1 ADR604.1 ADR636.1 ADR638.1 ADR656.1 ADR662.1 ADR673.1 ADR676.1 ADR679.1 ADR680.1 ADR682.1 ADR685.1 ADR695.1 ADR703.1 ADR705.1 ADR743.1 ADR777.1 ADR787.1 ADR789.1 ADR794.1 ADR798.1 ADR809.1 ADR813.1 ADR815.1 ADR818.1 ADR823.1 ADR841.1 ADR852.1 ADR853.1 ADR856.1 ADR865.1 ADR868.1 ADR913.1 ADR924.1 ADR927.1 ADR931.1 ADR932.1 ADR933.1 ADR936.1 ADR945.1 ADR948.1 ADR951.1 ADR984.1 ADR985.1 ADR990.1 ADW456.1 ADW463.1 ADW488.1 ADW492.1 ADW495.1 ADW496.1 ADW497.1 ADW499.1 ADW510.1 ADW560.1 ADW561.1 ADW566.1 ADW569.1 ADW600.1 ADW615.1 ADW675.1 ADW699.1 ADW720.1 ADW725.1 ADW749.1 ADW754.1 ADW757.1 ADW759.1 ADW761.1 ADW762.1 ADW766.1 ADW767.1 ADW769.1 ADW771.1 ADW773.1 ADW781.1 ADW790.1 ADW810.1 ADW822.1 ADW828.1 ADW830.1 ADW834.1 ADW841.1 ADW855.1 ADW857.1 ADW860.1 ADW862.1 ADW872.1 ADW876.1 ADW883.1 ADW897.1 ADW912.1 ADW915.1 ADW921.1 ADW935.1 ADW983.1 ADW984.1 ADW992.1 ADW998.1 AEH631.1 AEH637.1 AEH644.1 AEH648.1 AEH651.1 AEH654.1 AEH657.1 AEH664.1 AEH670.1 AEH673.1 AEH678.1 AEH680.1 AEH697.1 AEH699.1 AEH700.1 AEH702.1 AEH704.1 AEH706.1 AEH711.1 AEH714.1 AEH721.1 AEH723.1 AEH724.1 AEH728.1 AEH729.1 AEH730.1 AEH733.1 AEH745.1 AEH746.1 AEH747.1 AEH748.1 AEH756.1 AEH760.1 AEH761.1 AEH764.1 AEH767.1 AEH770.1 AEH772.1 AEH775.1 AEH803.1 AEH804.1 AEH812.1 AEH815.1 AEH821.1 AEH822.1 AEH825.1 AEH826.1 AEH831.1 AEH851.1 AEH853.1 AEH856.1 AEH862.1 AEH865.1 AEH872.1 AEH875.1 AEH877.1 AEH883.1 AEH898.1 AEH908.1 AEH918.1 AEH919.1 AEH926.1 AEH934.1 AEH938.1 AEH940.1 AEH944.1 AEH951.1 AEH953.1 AEH955.1 AEH960.1 AEH962.1 AEH972.1 AEH980.1 AEH982.1 AEH987.1 AEH996.1 AEJ005.1 AEJ024.1 AEJ026.1 AEJ027.1 AEJ033.1 AEJ035.1 AEJ036.1 AEJ037.1 AEJ039.1 AEJ040.1 AEJ046.1 AEJ047.1 AEJ049.1 AEJ054.1 AEJ066.1 AEJ078.1 AEJ085.1 AEJ092.1 AEJ097.1 AEJ099.1 AEJ100.1 AEJ101.1 AEJ103.1 AEJ105.1 AEJ106.1 AEJ111.1 AEJ113.1 AEJ115.1 AEJ116.1 AEJ121.1 AEJ129.1 AEJ132.1 AEJ134.1 AEJ135.1 AEJ136.1 AEJ141.1 AEJ142.1 AEJ145.1 AEJ148.1 AEJ149.1 AEJ151.1 AEJ156.1 AEJ164.1 AEJ166.1 AEJ167.1 AEJ171.1 AEJ173.1 AEJ187.1 AEJ188.1 AEJ189.1 AEJ190.1 AEJ193.1 AEJ194.1 AEJ196.1 AEJ203.1 AEJ204.1 AEJ213.1 AEJ214.1 AEJ216.1 AEJ241.1 AEJ243.1 AEJ248.1 AEJ251.1 AEJ252.1 AEJ257.1 AEJ272.1 AEM741.1 AEM743.1 AEM746.1 AEM754.1 AEM759.1 AEM761.1 AEM767.1 AEM768.1 AEM773.1 AEM777.1 AEM783.1 AEM789.1 AEM791.1 AEM795.1 AEM796.1 AEM797.1 AEM798.1 AEM799.1 AEM803.1 AEM809.1 AEM816.1 AEM817.1 AEM819.1 AEM820.1 AEM833.1 AEM834.1 AEM851.1 AEM852.1 AEM856.1 AEM857.1 AEM871.1 AEM873.1 AEM875.1 AEM877.1 AEM885.1 AEM887.1 AEM888.1 AEM889.1 AEM898.1 AEM900.1 AEM916.1 AEM917.1 AEM918.1 AEM919.1 AEM924.1 AEM941.1 AEM942.1 AEM945.1 AEM949.1 AEM951.1 AEM964.1 AEM965.1 AEM967.1 AEM968.1 AEM969.1 AEM970.1 AEM971.1 AEM972.1 AEM975.1 AEM979.1 AEM988.1 AEM989.1 AEN001.1 AEN010.1 AEN031.1 AEN048.1 AEN088.1 AEN120.1 AFB225.1 AFB349.1 AFB376.1 AFB394.1 AFB395.1 AFB396.1 AFB402.1 AFB404.1 AFB410.1 AFB413.1 AFB415.1 AFB418.1 AFB433.1 AFB434.1 AFB436.1 AFB440.1 AFB444.1 AFB446.1 AFB448.1 AFB451.1 AFB453.1 AFB472.1 AFB495.1 AFB500.1 AFB658.1 AFB903.1 AFB908.1 AFB923.1 AFB924.1 AFB926.1 AFB930.1 AFB936.1 AFB946.1 AFB951.1 AFB956.1 AFB959.1 AFB966.1 AFB974.1 AFB975.1 AFB982.1 AFB996.1 AFC002.1 AFG263.1 AFG274.1 AFG276.1 AFG283.1 AFG288.1 AFG295.1 AFG307.1 AFG308.1 AFG344.1 AFG376.1 AFG392.1 AFG399.1 AFG411.1 AFG412.1 AFG413.1 AFG419.1 AFG422.1 AFG429.1 AFG431.1 AFG432.1 AFG436.1 AFG446.1 AFG447.1 AFG451.1 AFG452.1 AFG471.1 AFG473.1 AFG476.1 AFG477.1 AFG485.1 AFG488.1 AFG496.1 AFG501.1 AFG505.1 AFG507.1 AFG529.1 AFG535.1 AFG541.1 AFG545.1 AFG560.1 AFG652.1 AFG658.1 AFG663.1 AFG668.1 AFG672.1 AFG679.1 AFG682.1 AFG685.1 AFG689.1 AFG704.1 AFG707.1 AFG723.1 AFG724.1 AFG726.1 AFG728.1 AFG730.1 AFG732.1 AFG737.1 AFG742.1 AFG750.1 AFG755.1 AFG770.1 AFG782.1 AFG807.1 AFG810.1 AFG814.1 AFG815.1 AFG819.1 AFG821.1 AFG823.1 AFG828.1 AFG829.1 AFG838.1 AFG846.1 AFG848.1 AFG851.1 AFG852.1 AFG857.1 AFG871.1 AFG873.1 AFG875.1 AFG882.1 AFG889.1 AFG895.1 AFG898.1 AFG904.1 AFG926.1 AFG929.1 AFG933.1 AFG937.1 AFG947.1 AFG951.1 AFG959.1 AFZ148.1 AFZ154.1 AFZ158.1 AFZ168.1 AFZ174.1 AFZ178.1 AFZ179.1 AFZ180.1 AFZ183.1 AFZ185.1 AFZ197.1 AFZ198.1 AFZ208.1 AFZ209.1 AFZ211.1 AFZ223.1 AFZ224.1 AFZ231.1 AFZ233.1 AFZ243.1 AFZ254.1 AFZ260.1 AFZ270.1 AFZ273.1 AFZ274.1 AFZ280.1 AFZ282.1 AFZ294.1 AFZ295.1 AFZ296.1 AFZ303.1 AFZ310.1 AFZ316.1 AFZ320.1 AFZ331.1 AFZ335.1 AFZ336.1 AFZ356.1 AFZ357.1 AFZ359.1 AFZ362.1 AFZ363.1 AFZ364.1 AFZ368.1 AFZ373.1 AFZ377.1 AFZ383.1 AFZ384.1 AFZ387.1 AFZ390.1 AFZ392.1 AFZ400.1 AFZ404.1 AFZ409.1 AFZ417.1 AFZ420.1 AFZ427.1 AFZ431.1 AFZ435.1 AFZ440.1 AFZ442.1 AFZ446.1 AFZ448.1 AFZ449.1 AFZ451.1 AFZ454.1 AFZ455.1 AFZ530.1 AFZ532.1 AFZ588.1 AFZ590.1 AFZ651.1 AFZ671.1 AFZ674.1 AFZ807.1 AFZ833.1 AFZ835.1 AFZ851.1 AFZ966.1 AFZ996.1 AGM602.1 AGM732.1 AGM764.1 AGM765.1 AGM766.1 AGM950.1 AGN188.1 AGN230.1 AGN231.1 AGN324.1 AGN418.1 AGN447.1 AGN461.1 AGN490.1 AGN552.1 AGN616.1 AGU383.1 AHD572.1 AHD578.1 AHD589.1 AHD612.1 AHD646.1 AHD648.1 AHD663.1 AHD677.1 AHD685.1 AHD686.1 AHD713.1 AHD818.1 AHD821.1 AHD822.1 AHK567.1 AHK715.1 AHK727.1 AHK778.1 AHK779.1 AHK897.1 AHK905.1 AHK906.1 AHK908.1 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 AHV587.1 AHV591.1 AHV603.1 AHV609.1 AHV679.1 AHV683.1 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 AHV863.1 AHV873.1 AHV887.1 AHV897.1 AHV921.1 AHV937.1 AHV945.1 AHV947.1 AHV965.1 AHV971.1 AHV975.1 AHV992.1 AHV999.1 AHW013.1 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 AJB359.1 AJP994.1 AJP995.1 AJR037.1 AJR053.1 AJR058.1 AJR073.1 AJR075.1 AJR076.1 AJR077.1 AJW278.1 AJW280.1 AJW285.1 AJW287.1 AJW290.1 AJW296.1 AJW310.1 AJW316.1 AJW328.1 AJW329.1 AJW332.1 AJW334.1 AJW336.1 AJW345.1 AJW365.1 AJW382.1 AJW384.1 AJW388.1 AJW393.1 AJW412.1 AJW422.1 AJW431.1 AJW461.1 AJW475.1 AJW487.1 AKB668.1 AKB892.1 AKU960.1 AKV412.1 AKV505.1 AKV522.1 AKV546.1 AKV579.1 AKV601.1 AKV608.1 AKV612.1 AKX057.1 AKX072.1 AKX078.1 AKX086.1 AKX143.1 AKX170.1 AKX174.1 AKX178.1 AKX189.1 AKX198.1 AKX201.1 AKX211.1 AKX233.1 AKX245.1 AKX260.1 AKX266.1 AKX268.1 AKX271.1 AKX351.1 AKX374.1 AKX384.1 AKX430.1 AKX434.1 AKX435.1 AKX504.1 AKX510.1 AKX628.1 AKX690.1 AKX701.1 AKX715.1 AKX739.1 AKX748.1 AKX750.1 AKX775.1 ALE569.1 ALE584.1 ALE588.1 ALE603.1 ALE605.1 ALE618.1 ALE624.1 ALE631.1 ALE638.1 ALE668.1 ALE675.1 ALE746.1 ALE753.1 ALE774.1 ALE777.1 ALE833.1 ALE881.1 ALE924.1 ALE931.1 ALE943.1 ALE944.1 ALE956.1 ALE985.1 ALF013.1 ALF015.1 ALF019.1 ALF030.1 ALF031.1 ALF042.1 ALF044.1 ALF070.1 ALF095.1 ALF137.1 ALF156.1 ALF174.1 ALF176.1 ALF177.1 ALJ181.1 ALJ185.1 ALJ186.1 ALJ217.1 ALJ221.1 ALJ257.1 ALJ268.1 ALJ273.1 ALJ293.1 ALJ294.1 ALJ296.1 ALJ297.1 ALJ336.1 ALJ342.1 ALJ346.1 ALJ358.1 ALJ360.1 ALJ394.1 ALJ402.1 ALJ403.1 ALJ410.1 ALJ411.1 ALJ460.1 ALJ777.1 ALJ839.1 ALJ872.1 ALJ909.1 ALJ917.1 ALJ928.1 ALJ936.1 ALJ943.1 ALJ949.1 ALJ951.1 ALJ954.1 ALJ958.1 ALJ984.1 ALJ992.1 ALJ995.1 ALK007.1 ALK043.1 ALN346.1 ALN365.1 ALN367.1 ALN378.1 ALN387.1 ALN401.1 ALN410.1 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2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.