Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

Agency Publication Date: February 1, 2018

Affected Products

Product: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some d

a. Product No. DTMB1D4: UDI 00643169543430 (Serial No. RPJ201956H, RPJ202805H) (EXPANSION: Serial No. RPJ201660H, RPJ201661H, RPJ201972H, RPJ202145H, RPJ202821H, RPJ203208H, RPJ203209H, RPJ203826H); b. Product No. DTMB1Q1: UDI 00643169705784 (Serial No. RPU201108H) (EXPANSION: Serial No. RPU201289H, RPU201290H, RPU201291H, RPU201292H, RPU201293H, RPU201295H, RPU201296H, RPU201297H, RPU201298H, RPU201299H, RPU201300H, RPU201301H, RPU201302H, RPU201303H, RPU201305H, RPU201306H, RPU201287H, RPU201288H, RPU201619H, RPU201621H, RPU201635H, RPU201304H); c. Product No. DTMB1QQ: UDI 00643169929647 (Serial No. RPE219331H, RPE218183H), 00643169543386 (Serial No. RPE201417H, RPE204789H, RPE206207H, RPE207850H, RPE209095H, RPE212027H) (EXPANSION: Serial No. RPE215624H, RPE217014H, RPE200352H, RPE200394H, RPE201115H, RPE201328H, RPE202133H, RPE202941H, RPE203460H, RPE203771H, RPE203998H, RPE204209H, RPE204790H, RPE204791H, RPE204792H, RPE205432H, RPE206879H, RPE206886H, RPE208041H, RPE208241H, RPE208355H, RPE208369H, RPE208613H, RPE209037H, RPE209093H, RPE209135H, RPE209190H, RPE209194H, RPE209553H, RPE210227H, RPE210228H, RPE210672H, RPE210673H, RPE210734H, RPE210841H, RPE210844H, RPE210869H, RPE210870H, RPE210874H, RPE210875H, RPE211011H, RPE211012H, RPE211731H, RPE211732H, RPE211734H, RPE211736H, RPE211820H, RPE211858H, RPE211859H, RPE213564H, RPE214135H, RPE214544H, RPE214545H, RPE214546H, RPE215260H, RPE215628H, RPE216247H, RPE217013H, RPE217332H, RPE217335H, RPE217399H, RPE217443H, RPE217444H, RPE217446H, RPE217850H, RPE218146H, RPE218307H, RPE218308H, RPE219117H, RPE210877H, RPE215451H, RPE215625H, RPE215627H, RPE217445H, RPE217849H, RPE218148H, RPE215626H); EXPANSION: d. Product No. DTMB1D1: UDI 00643169705791 (Serial No. RPV200926H, RPV201075H, RPV201757H, RPV201758H)

Product: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

a. Product No. DTMC1D1: UDI 00643169705807 (Serial No. RPW200289H); b. Product No. DTMC1QQ: UDI 00643169565272 (Serial No. RPL201034H) (EXPANSION: Serial No. RPL200052H, RPL200534H, RPL201039H, RPL201059H, RPL201235H, RPL201236H, RPL201454H, RPL201645H, RPL201664H, RPL201234H)

Product: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4)

a. Product No. DTBB1QQ: UDI 00643169530218 (Serial No. BLK204122H) (EXPANSION: Serial No. BLK202087H, BLK203257H, BLK204050H, BLK204435H); b. Product No. DTBA1QQ: UDI 00643169007222 (Serial No. BLC224272H) (EXPANSION: Serial No. BLC200490H, BLC205825H, BLC205826H, BLC205827H, BLC206202H, BLC206263H, BLC208305H, BLC208471H, BLC211869H, BLC215219H, BLC215544H, BLC218906H, BLC219515H, BLC220190H, BLC221044H, BLC221045H, BLC221046H, BLC221047H, BLC222903H, BLC223278H, BLC223517H, BLC224374H, BLC224553H, BLC224554H, BLC224555H, BLC224556H, BLC224655H, BLC225498H, BLC225502H, BLC225682H, BLC225734H, BLC226030H, BLC226031H, BLC226032H, BLC226033H, BLC226034H, BLC226035H, BLC226040H, BLC227270H, BLC227659H, BLC227662H, BLC205767H, BLC205828H, BLC211870H, BLC226988H, BLC227212H, BLC227728H, BLC227740H), 00643169530171 (Serial No. BLC227175H, BLC227641H); c. Product No. DTBB1D1: UDI 00643169007185 (Serial No. BLO204984H) EXPANSION: Serial No. BLO210650H, BLO212502H, BLO201695H, BLO204429H, BLO206930H, BLO207702H, BLO208974H, BLO210408H, BLO210409H, BLO210770H, BLO212131H, BLO212481H, BLO212491H, BLO212493H, BLO212503H, BLO212504H, BLO212505H, BLO212506H, BLO212507H, BLO212729H, BLO213454H, BLO213467H, BLO213468H, BLO213592H, BLO213780H, BLO213781H, BLO201347H, BLO201436H, BLO208063H, BLO212501H, BLO213783H, BLO213784H, BLO213786H); d. Product No. DTBA1D1: UDI 00643169530140 (Serial No. BLF253790H, BLF254092H, BLF250740H, BLF251155H), 00643169007246 (Serial No. BLF216780H, BLF231229H) (EXPANSION: Serial No. BLF243217H, BLF247858H, BLF202387H, BLF202535H, BLF204112H, BLF205853H, BLF206730H, BLF206788H, BLF207518H, BLF207678H, BLF210779H, BLF210782H, BLF211003H, BLF211357H, BLF211358H, BLF213450H, BLF213658H, BLF218473H, BLF219583H, BLF219667H, BLF221248H, BLF222061H, BLF224098H, BLF224106H, BLF224214H, BLF224230H, BLF224242H, BLF224253H, BLF224260H, BLF224386H, BLF224483H, BLF227680H, BLF227903H, BLF227947H, BLF228849H, BLF230968H, BLF232235H, BLF232254H, BLF234692H, BLF235138H, BLF237753H, BLF238241H, BLF238700H, BLF239221H, BLF239916H, BLF243268H, BLF243674H, BLF245571H, BLF245572H, BLF245893H, BLF246563H, BLF247381H, BLF247435H, BLF247466H, BLF248396H, BLF248398H, BLF248399H, BLF248400H, BLF248401H, BLF248402H, BLF248403H, BLF248464H, BLF249952H, BLF250022H, BLF250142H, BLF250143H, BLF250389H, BLF250392H, BLF250393H, BLF250751H, BLF251380H, BLF253085H, BLF253406H, BLF253407H, BLF253618H, BLF253795H, BLF253796H, BLF253798H, BLF253801H, BLF253802H, BLF253803H, BLF253806H, BLF253820H, BLF253853H, BLF254774H, BLF254776H, BLF254777H, BLF254778H, BLF254779H, BLF200834H, BLF205341H, BLF218472H, BLF218474H, BLF220892H, BLF224264H, BLF250752H, BLF205821H, BLF210550H, BLF222642H, BLF251852H, BLF253755H, BLF253852H, BLF253797H, BLF253799H), 00643169929296 (Serial No. BLF255165H, BLF255598H; e. Product No. DTBA1D4: UDI 00643169530157 (Serial No. BLE219903H), 00643169929302 (Serial No. BLE220200H), EXPANSION: UDI 00643169007239 (Serial No. BLE205339H, BLE203253H, BLE203582H, BLE203583H, BLE204049H, BLE205304H, BLE209377H, BLE209554H, BLE212368H, BLE213926H, BLE218673H, BLE218892H, BLE218902H, BLE219909H, BLE219911H, BLE219914H, BLE208468H, BLE204048H, BLE214123H, BLE217805H, BLE219910H, BLE220390H, BLE219912H); EXPANSION: f. Product No. DTBB1Q1: UDI 00643169017993 (Serial No. BLM201868H, BLM202644H, BLM202773H, BLM202775H); g. Product No. DTBA1Q1: UDI 00643169018013 (Serial No, BLD202507H, BLD202778H, BLD203541H, BLD207024H, BLD208443H, BLD209856H, BLD210102H, BLD210103H, BLD210175H, BLD210220H, BLD210223H, BLD210251H, BLD210257H, BLD210258H, BLD210259H, BLD210260H, BLD211370H, BLD211371H, BLD211681H, BLD211682H, BLD202666H, BLD210700H, BLD210738H, BLD211680H, BLD210699H); h. Product No. DTBB1D4: UDI 00643169007178 (Serial No. BLN201692H, BLN201722H, BLN202203H, BLN202897H, BLN204159H, BLN202355H)

Product: Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e. Evera MRI S DR ICD DF4 (Product No. DDMC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricu

a. Product No. DDMB1D1: UDI 00643169929197 (Serial No. CWA207109H) (EXPANSION Serial No. CWA207132H, CWA200074H, CWA200576H, CWA200619H, CWA200837H, CWA200888H, CWA201175H, CWA201443H, CWA201760H, CWA201771H, CWA203003H, CWA203389H, CWA204111H, CWA204889H, CWA204890H, CWA205625H, CWA205694H, CWA205695H, CWA205703H, CWA206083H, CWA206177H, CWA206178H, CWA206179H, CWA206180H, CWA206330H, CWA206666H, CWA206667H, CWA206779H, CWA206780H, CWA207122H, CWA207123H, CWA207125H, CWA207126H, CWA207128H, CWA207131H, CWA207218H, CWA207220H, CWA206176H, CWA205686H, CWA205697H, CWA206175H, CWA206785H, CWA207120H), 00643169717282 (Serial No. CWA200012H, CWA202259H, CWA203498H); b. Product No. DDMB1D4: UDI 00643169929203 (Serial No. PFZ228501H, PFZ228504H, PFZ228590H, PFZ228836H, PFZ228838H, PFZ229236H, PFZ229520H), 00643169314092 (Serial No. PFZ223779H, PFZ214605H) (EXPANSION: Serial No. PFZ203846H, PFZ200814H, PFZ202951H, PFZ203501H, PFZ203757H, PFZ204555H, PFZ206452H, PFZ206453H, PFZ206456H, PFZ206595H, PFZ206712H, PFZ206881H, PFZ206900H, PFZ209342H, PFZ209675H, PFZ210215H, PFZ210528H, PFZ210537H, PFZ210538H, PFZ210539H, PFZ210791H, PFZ214550H, PFZ214823H, PFZ214971H, PFZ215285H, PFZ215626H, PFZ215627H, PFZ215630H, PFZ215631H, PFZ215876H, PFZ216099H, PFZ216100H, PFZ216973H, PFZ216974H, PFZ217247H, PFZ218221H, PFZ218432H, PFZ218433H, PFZ218435H, PFZ218436H, PFZ218437H, PFZ218877H, PFZ219142H, PFZ219143H, PFZ219373H, PFZ220377H, PFZ221425H, PFZ221716H, PFZ221724H, PFZ221725H, PFZ221726H, PFZ222665H, PFZ223869H, PFZ225847H, PFZ225849H, PFZ225850H, PFZ225851H, PFZ225852H, PFZ225854H, PFZ226023H, PFZ226092H, PFZ226179H, PFZ226185H, PFZ226442H, PFZ226443H, PFZ226513H, PFZ226586H, PFZ226924H, PFZ227065H, PFZ227408H, PFZ227453H, PFZ227454H, PFZ227455H, PFZ227456H, PFZ227778H, PFZ227779H, PFZ227780H, PFZ227781H, PFZ228380H, PFZ228459H, PFZ228560H, PFZ229000H, PFZ229904H, PFZ230774H, PFZ210536H, PFZ215361H, PFZ222655H, PFZ218434H, PFZ225120H, PFZ225848H, PFZ226091H, PFZ236813H, PFZ236991H, PFZ230454H); c. Product No. DVMB1D4: UDI 00643169314153 (Serial No. PKZ203327H, PKZ210673H) (EXPANSION: Serial No. PKZ202755H, PKZ203168H, PKZ204640H, PKZ205375H, PKZ205377H, PKZ206276H, PKZ206383H, PKZ208113H, PKZ208114H, PKZ208527H, PKZ208981H, PKZ210816H, PKZ210819H, PKZ210927H, PKZ210928H, PKZ210939H, PKZ211270H, PKZ211617H, PKZ211619H, PKZ211620H, PKZ211715H, PKZ210817H, PKZ211289H); d. Product No. DDMC3D1: UDI 00643169717244 (Serial No. CWC200055H); EXPANSION: e. Product No. DDMC3D4: UDI 00643169314139 (Serial No. PHZ201438H)

Product: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some

a. Product No. DTMA1D1: UDI 00643169705777 (Serial No. RPT200245H) (EXPANSION Serial No. RPT201653H, RPT200308H, RPT201033H, RPT202625H, RPT201913H, RPT202623H, RPT202624H, RPT202627H, RPT202626H), 00643169929531 (Serial No. RPT202182H); b. Product No. DTMA1QQ: UDI 00643169543362 (Serial No. RPA202057H) (EXPANSION: Serial No. RPA200224H, RPA200472H, RPA200673H, RPA201732H, RPA201733H, RPA202258H, RPA202454H, RPA202455H, RPA202649H, RPA202650H, RPA202651H, RPA202652H, RPA202653H, RPA203381H, RPA203416H, RPA203546H, RPA203547H, RPA204428H, RPA204605H, RPA204606H, RPA201333H, RPA202259H), 00643169929562 (Serial No. RPA204495H); EXPANSION: c. Product No. DTMA1D4: UDI 00643169543416 (Serial No. RPC200266H, RPC200772H, RPC200830H, RPC201028H, RPC201030H, RPC201382H, RPC201056H, RPC201383H); d. Product No. DTMA1Q1: UDI 00643169705760 (Serial No. RPS200939H)

Product: Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DVBB1D1); f. Evera XT VR ICD DF4 (Product No. DVBB1D4); EXPANSION: g. Evera S DR ICD DF4 (Product No. DDBC3D4); h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); i. Ever

a. Product No. DDBC3D1: UDI 00643169018044 (Serial No. BWG204574H) (EXPANSION: Serial No. BWG200861H, BWG201119H, BWG201913H, BWG204028H, BWG204300H, BWG205740H, BWG205936H, BWG206156H, BWG206745H, BWG206747H, BWG206882H, BWG206883H, BWG206884H, BWG206885H, BWG207389H, BWG207390H); b. Product No. DVBC3D1: UDI 00643169929852 (Serial No. BWM204635H), 00643169017900 (Serial No. BWM204192H) (EXPANSION: Serial No. BWM201169H, BWM202293H, BWM203256H, BWM203852H, BWM200338H, BWM203851H, BWM204508H); c. Product No. DVBC3D4: UDI 00643169017887 (Serial No. BWL204405H) (EXPANSION: Serial No. BWL202873H, BWL203306H, BWL203955H, BWL205870H, BWL201180H, BWL202937H, BWL205860H); d. Product No. DDBB1D1: UDI 00643169018099 (Serial No. BWC223253H, BWC201978H), 00643169530263 (Serial No. BWC233374H, BWC234767H, BWC234772H) (EXPANSION: Serial No. BWC236143H, BWC214218H, BWC201100H, BWC203011H, BWC203472H, BWC204674H, BWC205108H, BWC206553H, BWC206785H, BWC207821H, BWC207822H, BWC207823H, BWC210629H, BWC212493H, BWC214272H, BWC214763H, BWC216241H, BWC217842H, BWC217843H, BWC217844H, BWC218221H, BWC218224H, BWC224331H, BWC226302H, BWC226305H, BWC226657H, BWC227492H, BWC227493H, BWC228308H, BWC228309H, BWC228351H, BWC228836H, BWC229030H, BWC229087H, BWC231807H, BWC231876H, BWC231928H, BWC232958H, BWC234187H, BWC234515H, BWC234517H, BWC234518H, BWC234519H, BWC234522H, BWC234525H, BWC234559H, BWC234722H, BWC235087H, BWC235655H, BWC235967H, BWC235968H, BWC235969H, BWC236085H, BWC236087H, BWC236140H, BWC236141H, BWC236142H, BWC236144H, BWC236182H, BWC236290H, BWC236722H, BWC236723H, BWC236724H, BWC236775H, BWC237274H, BWC238797H, BWC239432H, BWC239866H, BWC216082H, BWC218086H, BWC224128H), 00643169929111 (Serial No. BWC240255H, BWC241043H); e. Product No. DVBB1D1: UDI 00643169017955 (Serial No. BWI208876H) (EXPANSION: Serial No. BWI209212H, BWI200678H, BWI200679H, BWI200980H, BWI202079H, BWI204182H, BWI204201H, BWI206252H, BWI208151H, BWI209159H, BWI209879H, BWI212202H, BWI214590H, BWI215505H, BWI215752H, BWI216623H, BWI216981H, BWI217952H, BWI217739H, BWI217941H, BWI218177H, BWI211281H, BWI217953H, BWI217955H); f. Product No. DVBB1D4: UDI 00643169017948 (Serial No. BWH201158H, BWH214640H) (EXPANSION: Serial No. BWH203008H, BWH203759H, BWH207797H, BWH209311H, BWH209313H, BWH210341H, BWH211052H, BWH211053H, BWH212583H, BWH212739H, BWH212740H, BWH213523H, BWH213531H, BWH214545H, BWH214546H, BWH217150H, BWH217312H, BWH218316H, BWH218386H, BWH219837H, BWH220818H, BWH221001H, BWH222521H, BWH224286H, BWH224297H, BWH223806H); EXPANSION: g. Product No. DDBC3D4: UDI 00643169018020 (Serial No. BWF200823H, BWF204395H, BWF206087H, BWF201831H, BWF202542H, BWF205758H, BWF201407H, BWF203531H, BWF205759H, BWF205852H); h. Product No. DDBB1D1G: UDI 00643169777606 (Serial No. BWC235910H); i. Product No. DDBB1D4: UDI 00643169018082 (Serial No. BWB206139H, BWB218529H, BWB201323H, BWB202548H, BWB202741H, BWB203522H, BWB203524H, BWB203525H, BWB203527H, BWB203528H, BWB203529H, BWB204481H, BWB205332H, BWB206095H, BWB206099H, BWB206476H, BWB207118H, BWB210704H, BWB212480H, BWB212482H, BWB212577H, BWB217513H, BWB218439H, BWB218616H, BWB218957H, BWB220702H, BWB221924H, BWB222431H, BWB223026H, BWB223413H, BWB224318H, BWB227088H, BWB229740H, BWB230009H, BWB230011H, BWB230116H, BWB203526H, BWB211923H, BWB229726H)

Product: Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1); d. Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia,

a. Product No. DVFB1D1: UDI 00643169717213 (Serial No. CWG200402H) (EXPANSION: Serial No. CWG200403H, CWG200404H, CWG200406H, CWG200897H, CWG200898H, CWG202225H, CWG202244H, CWG202762H, CWG203250H, CWG203455H, CWG200147H, CWG200899H, CWG202761H); b. Product No. DVFB1D4: UDI 00643169566422 (Serial No. PKX202448H, PKX205417H, PKX205779H, PKX209277H) (EXPANSION: Serial No. PKX211818H, PKX201092H, PKX201561H, PKX201910H, PKX202355H, PKX202386H, PKX202879H, PKX202881H, PKX202882H, PKX202883H, PKX202884H, PKX202885H, PKX202960H, PKX203135H, PKX203209H, PKX203946H, PKX203947H, PKX203950H, PKX204060H, PKX204170H, PKX204372H, PKX204490H, PKX204625H, PKX204629H, PKX204640H, PKX205178H, PKX205179H, PKX205181H, PKX205239H, PKX205240H, PKX205268H, PKX205269H, PKX205659H, PKX205660H, PKX205661H, PKX205662H, PKX205663H, PKX205665H, PKX205666H, PKX205673H, PKX205774H, PKX206142H, PKX206740H, PKX206996H, PKX207013H, PKX207619H, PKX207870H, PKX208254H, PKX209305H, PKX210996H, PKX211165H, PKX211167H, PKX211168H, PKX211169H, PKX211170H, PKX211195H, PKX211196H, PKX211198H, PKX211222H, PKX211223H, PKX211226H, PKX211499H, PKX211847H, PKX211848H, PKX212194H, PKX212195H, PKX212196H, PKX212363H, PKX212763H, PKX212873H, PKX213476H, PKX213477H, PKX213633H, PKX214090H, PKX214355H, PKX214374H, PKX215541H, PKX210995H, PKX210999H, PKX211000H, PKX211029H, PKX211031H, PKX212362H, PKX211654H, PKX212197H), 00643169929913 (Serial No. PKX212710H, PKX213420H); EXPANSION: c. Product No. DVFC3D1: UDI 00643169717206 (Serial No. CWJ200155H); d. Product No. DVFC3D4: UDI 00643169566446 (Serial No. PMX200139H)

Product: Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

a. Product No. DVAB1D1: UDI 00643169566347 (Serial No. BWN201126H) (EXPANSION: Serial No. BWN202016H, BWN202327H, BWN202334H, BWN202335H); EXPANSION: b. Product No. DVAB1D4: UDI 00643169566354 (Serial No. BWP201614H, BWP201658H, BWP201660H, BWP201669H, BWP201782H, BWP201783H), 00643169929760 (Serial No. BWP201661H)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78888

Status: Resolved

Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Manufactured In: United States

Units Affected: 8 products (951 devices total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.

Affected Products