Recall archive / FDA device enforcement

Model B35200 - Percept PC BrainSense Implantable Neurostimulator — FDA record Z-0418-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 19, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Reason: During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
Classification: Class II
Recalling firm: Medtronic Neuromodulation
Quantity: 10,006 units
Agency-reported status: Ongoing
Source record identifier: Z-0418-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	GTIN 00763000253363, Serial Numbers: NPI714835H, NPI714811H, NPI714812H, NPI714814H, NPI714816H, NPI714817H, NPI714819H, NPI714820H, NPI714750H, NPI714764H, NPI714771H, NPI714794H, NPI714682H, NPI714709H, NPI714710H, NPI714594H, NPI714598H, NPI714599H, NPI714602H, NPI714603H, NPI714606H, NPI714564H, NPI714572H, NPI714574H, NPI714587H, NPI714588H, NPI714589H, NPI714373H, NPI714379H, NPI714331H, NPI714346H, NPI714358H, NPI714378H, NPI714128H, NPI714160H, NPI714060H, NPI713947H, NPI713956H, NPI713957H, NPI714001H, NPI714017H, NPI713948H, NPI713949H, NPI713951H, NPI713952H, NPI713953H, NPI713954H, NPI713955H, NPI713829H, NPI713371H, NPI713372H, NPI713422H, NPI713242H, NPI713188H, NPI712940H, NPI712785H, NPI712637H, NPI712405H, NPI712411H, NPI712412H, NPI712341H, NPI712302H, NPI712256H, NPI711876H, NPI711841H, NPI711475H, NPI711476H, NPI710876H, NPI710765H, NPI710561H, NPI710071H, NPI709964H, NPI709680H, NPI709654H, NPI709655H, NPI709575H, NPI708692H, NPI708699H, 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NPI707013H, NPI707014H, NPI707015H, NPI707016H, NPI707017H, NPI70701...

Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00763000253363, Serial Numbers: NPI714835H, NPI714811H, NPI714812H, NPI714814H, NPI714816H, NPI714817H, NPI714819H, NPI714820H, NPI714750H, NPI714764H, NPI714771H, NPI714794H, NPI714682H, NPI714709H, NPI714710H, NPI714594H, NPI714598H, NPI714599H, NPI714602H, NPI714603H, NPI714606H, NPI714564H, NPI714572H, NPI714574H, NPI714587H, NPI714588H, NPI714589H, NPI714373H, NPI714379H, NPI714331H, NPI714346H, NPI714358H, NPI714378H, NPI714128H, NPI714160H, NPI714060H, NPI713947H, NPI713956H, NPI713957H, NPI714001H, NPI714017H, NPI713948H, NPI713949H, NPI713951H, NPI713952H, NPI713953H, NPI713954H, NPI713955H, NPI713829H, NPI713371H, NPI713372H, NPI713422H, NPI713242H, NPI713188H, NPI712940H, NPI712785H, NPI712637H, NPI712405H, NPI712411H, NPI712412H, NPI712341H, NPI712302H, NPI712256H, NPI711876H, NPI711841H, NPI711475H, NPI711476H, NPI710876H, NPI710765H, NPI710561H, NPI710071H, NPI709964H, NPI709680H, NPI709654H, NPI709655H, NPI709575H, NPI708692H, NPI708699H, NPI708702H, NPI708709H, NPI708675H, NPI708653H, NPI708635H, NPI708457H, NPI708415H, NPI708417H, NPI708425H, NPI708367H, NPI708376H, NPI708358H, NPI708316H, NPI708288H, NPI708289H, NPI708292H, NPI708295H, NPI708299H, NPI708300H, NPI708305H, NPI708306H, NPI708309H, NPI708258H, NPI708262H, NPI708273H, NPI708127H, NPI708128H, NPI708153H, NPI708101H, NPI708102H, NPI708103H, NPI708106H, NPI708107H, NPI708110H, NPI708112H, NPI708113H, NPI708114H, NPI708117H, NPI708118H, NPI708120H, NPI708121H, NPI708123H, NPI708124H, NPI708125H, NPI708079H, NPI708080H, NPI708082H, NPI708083H, NPI708084H, NPI708085H, NPI708086H, NPI708087H, NPI708088H, NPI708089H, NPI708090H, NPI708091H, NPI708092H, NPI708093H, NPI708094H, NPI708095H, NPI708096H, NPI708097H, NPI708100H, NPI708105H, NPI708108H, NPI708109H, NPI708116H, NPI708126H, NPI708056H, NPI708059H, NPI708060H, NPI708062H, NPI708063H, NPI708064H, NPI708065H, NPI708066H, NPI708067H, NPI708068H, NPI708070H, NPI708071H, NPI708073H, NPI708074H, NPI708076H, NPI708077H, NPI708078H, NPI708081H, NPI708014H, NPI708037H, NPI708038H, NPI708039H, NPI708040H, NPI708041H, NPI708042H, NPI708043H, NPI708044H, NPI708045H, NPI708046H, NPI708048H, NPI708049H, NPI708050H, NPI708055H, NPI708057H, NPI707998H, NPI707999H, NPI708001H, NPI708002H, NPI708003H, NPI708004H, NPI708005H, NPI708007H, NPI708008H, NPI708009H, NPI708011H, NPI708012H, NPI708013H, NPI708015H, NPI708016H, NPI708017H, NPI708018H, NPI708020H, NPI708021H, NPI708022H, NPI708023H, NPI708024H, NPI708025H, NPI708026H, NPI708027H, NPI708028H, NPI708030H, NPI708031H, NPI708033H, NPI708034H, NPI708036H, NPI707947H, NPI707955H, NPI707956H, NPI707961H, NPI707964H, NPI707970H, NPI707972H, NPI707975H, NPI707978H, NPI707979H, NPI707982H, NPI707983H, NPI707985H, NPI707986H, NPI707987H, NPI707989H, NPI707990H, NPI707991H, NPI707992H, NPI707993H, NPI707995H, NPI707996H, NPI707997H, NPI708000H, NPI707942H, NPI707943H, NPI707944H, NPI707945H, NPI707946H, NPI707948H, NPI707949H, NPI707950H, NPI707951H, NPI707952H, NPI707953H, NPI707954H, NPI707957H, NPI707958H, NPI707959H, NPI707962H, NPI707963H, NPI707966H, NPI707968H, NPI707969H, NPI707971H, NPI707974H, NPI707976H, NPI707977H, NPI707918H, NPI707919H, NPI707920H, NPI707922H, NPI707923H, NPI707924H, NPI707925H, NPI707927H, NPI707928H, NPI707929H, NPI707930H, NPI707931H, NPI707932H, NPI707934H, NPI707935H, NPI707937H, NPI707938H, NPI707939H, NPI707880H, NPI707881H, NPI707883H, NPI707884H, NPI707885H, NPI707886H, NPI707888H, NPI707890H, NPI707905H, NPI707907H, NPI707914H, NPI707916H, NPI707870H, NPI707871H, NPI707872H, NPI707873H, NPI707874H, NPI707875H, NPI707877H, NPI707879H, NPI707889H, NPI707893H, NPI707894H, NPI707895H, NPI707896H, NPI707897H, NPI707898H, NPI707899H, NPI707900H, NPI707901H, NPI707902H, NPI707846H, NPI707847H, NPI707848H, NPI707849H, NPI707856H, NPI707857H, NPI707858H, NPI707860H, NPI707861H, NPI707862H, NPI707864H, NPI707865H, NPI707867H, NPI707868H, NPI707869H, NPI707828H, NPI707830H, NPI707831H, NPI707832H, NPI707833H, NPI707834H, NPI707835H, NPI707836H, NPI707837H, NPI707838H, NPI707839H, NPI707840H, NPI707841H, NPI707842H, NPI707843H, NPI707844H, NPI707845H, NPI707851H, NPI707852H, NPI707855H, NPI707811H, NPI707812H, NPI707813H, NPI707814H, NPI707816H, NPI707818H, NPI707819H, NPI707820H, NPI707821H, NPI707822H, NPI707824H, NPI707791H, NPI707792H, NPI707794H, NPI707795H, NPI707797H, NPI707798H, NPI707799H, NPI707800H, NPI707802H, NPI707804H, NPI707805H, NPI707806H, NPI707807H, NPI707808H, NPI707809H, NPI707774H, NPI707776H, NPI707777H, NPI707779H, NPI707780H, NPI707782H, NPI707783H, NPI707784H, NPI707786H, NPI707788H, NPI707789H, NPI707790H, NPI707749H, NPI707750H, NPI707752H, NPI707753H, NPI707754H, NPI707755H, NPI707756H, NPI707757H, NPI707758H, NPI707762H, NPI707763H, NPI707764H, NPI707765H, NPI707766H, NPI707767H, NPI707768H, NPI707769H, NPI707770H, NPI707771H, NPI707772H, NPI707720H, NPI707721H, NPI707722H, NPI707723H, NPI707724H, NPI707725H, NPI707727H, NPI707728H, NPI707730H, NPI707731H, NPI707732H, NPI707733H, NPI707734H, NPI707735H, NPI707737H, NPI707738H, NPI707739H, NPI707740H, NPI707741H, NPI707743H, NPI707744H, NPI707745H, NPI707712H, NPI707713H, NPI707714H, NPI707684H, NPI707689H, NPI707690H, NPI707691H, NPI707696H, NPI707698H, NPI707699H, NPI707700H, NPI707702H, NPI707704H, NPI707705H, NPI707707H, NPI707708H, NPI707664H, NPI707666H, NPI707668H, NPI707672H, NPI707673H, NPI707674H, NPI707675H, NPI707676H, NPI707677H, NPI707679H, NPI707681H, NPI707682H, NPI707683H, NPI707686H, NPI707688H, NPI707648H, NPI707649H, NPI707650H, NPI707651H, NPI707652H, NPI707654H, NPI707655H, NPI707656H, NPI707658H, NPI707659H, NPI707660H, NPI707661H, NPI707662H, NPI707663H, NPI707670H, NPI707671H, NPI707592H, NPI707597H, NPI707598H, NPI707599H, NPI707617H, NPI707621H, NPI707622H, NPI707623H, NPI707624H, NPI707625H, NPI707626H, NPI707627H, NPI707628H, NPI707629H, NPI707630H, NPI707631H, NPI707632H, NPI707633H, NPI707635H, NPI707637H, NPI707639H, NPI707640H, NPI707641H, NPI707642H, NPI707643H, NPI707644H, NPI707645H, NPI707646H, NPI707647H, NPI707653H, NPI707657H, NPI707581H, NPI707582H, NPI707583H, NPI707585H, NPI707586H, NPI707587H, NPI707588H, NPI707589H, NPI707590H, NPI707591H, NPI707593H, NPI707594H, NPI707595H, NPI707596H, NPI707600H, NPI707601H, NPI707602H, NPI707603H, NPI707605H, NPI707606H, NPI707607H, NPI707610H, NPI707611H, NPI707612H, NPI707613H, NPI707614H, NPI707615H, NPI707616H, NPI707618H, NPI707569H, NPI707570H, NPI707571H, NPI707572H, NPI707573H, NPI707574H, NPI707575H, NPI707576H, NPI707577H, NPI707578H, NPI707579H, NPI707580H, NPI707536H, NPI707537H, NPI707538H, NPI707539H, NPI707541H, NPI707542H, NPI707543H, NPI707544H, NPI707545H, NPI707546H, NPI707547H, NPI707548H, NPI707549H, NPI707550H, NPI707551H, NPI707552H, NPI707553H, NPI707554H, NPI707555H, NPI707556H, NPI707557H, NPI707558H, NPI707559H, NPI707560H, NPI707561H, NPI707562H, NPI707563H, NPI707564H, NPI707565H, NPI707566H, NPI707567H, NPI707568H, NPI707513H, NPI707514H, NPI707515H, NPI707516H, NPI707517H, NPI707518H, NPI707519H, NPI707520H, NPI707521H, NPI707522H, NPI707523H, NPI707524H, NPI707525H, NPI707526H, NPI707530H, NPI707531H, NPI707533H, NPI707534H, NPI707535H, NPI707484H, NPI707485H, NPI707490H, NPI707491H, NPI707492H, NPI707493H, NPI707494H, NPI707495H, NPI707496H, NPI707497H, NPI707498H, NPI707500H, NPI707501H, NPI707502H, NPI707506H, NPI707507H, NPI707508H, NPI707509H, NPI707439H, NPI707440H, NPI707441H, NPI707443H, NPI707444H, NPI707445H, NPI707446H, NPI707447H, NPI707449H, NPI707450H, NPI707452H, NPI707453H, NPI707454H, NPI707455H, NPI707456H, NPI707457H, NPI707458H, NPI707459H, NPI707460H, NPI707461H, NPI707462H, NPI707463H, NPI707464H, NPI707465H, NPI707466H, NPI707467H, NPI707468H, NPI707469H, NPI707470H, NPI707471H, NPI707472H, NPI707473H, NPI707474H, NPI707476H, NPI707477H, NPI707478H, NPI707479H, NPI707480H, NPI707482H, NPI707483H, NPI707486H, NPI707487H, NPI707488H, NPI707402H, NPI707406H, NPI707407H, NPI707408H, NPI707410H, NPI707412H, NPI707414H, NPI707415H, NPI707416H, NPI707417H, NPI707418H, NPI707420H, NPI707421H, NPI707422H, NPI707423H, NPI707424H, NPI707425H, NPI707426H, NPI707427H, NPI707428H, NPI707429H, NPI707430H, NPI707431H, NPI707432H, NPI707433H, NPI707434H, NPI707435H, NPI707436H, NPI707437H, NPI707438H, NPI707351H, NPI707352H, NPI707353H, NPI707354H, NPI707355H, NPI707357H, NPI707358H, NPI707359H, NPI707374H, NPI707375H, NPI707376H, NPI707377H, NPI707378H, NPI707379H, NPI707380H, NPI707381H, NPI707382H, NPI707383H, NPI707386H, NPI707394H, NPI707396H, NPI707397H, NPI707398H, NPI707399H, NPI707400H, NPI707401H, NPI707403H, NPI707404H, NPI707336H, NPI707338H, NPI707339H, NPI707341H, NPI707342H, NPI707343H, NPI707364H, NPI707367H, NPI707368H, NPI707369H, NPI707373H, NPI707385H, NPI707387H, NPI707388H, NPI707389H, NPI707390H, NPI707392H, NPI707393H, NPI707395H, NPI707306H, NPI707308H, NPI707309H, NPI707310H, NPI707311H, NPI707312H, NPI707313H, NPI707315H, NPI707316H, NPI707317H, NPI707318H, NPI707319H, NPI707320H, NPI707321H, NPI707322H, NPI707323H, NPI707326H, NPI707327H, NPI707328H, NPI707329H, NPI707331H, NPI707332H, NPI707334H, NPI707335H, NPI707277H, NPI707278H, NPI707279H, NPI707280H, NPI707282H, NPI707283H, NPI707284H, NPI707285H, NPI707286H, NPI707287H, NPI707288H, NPI707289H, NPI707290H, NPI707291H, NPI707292H, NPI707293H, NPI707294H, NPI707296H, NPI707297H, NPI707299H, NPI707300H, NPI707301H, NPI707302H, NPI707303H, NPI707304H, NPI707307H, NPI707314H, NPI707249H, NPI707250H, NPI707252H, NPI707253H, NPI707255H, NPI707256H, NPI707257H, NPI707258H, NPI707259H, NPI707261H, NPI707262H, NPI707263H, NPI707268H, NPI707269H, NPI707270H, NPI707271H, NPI707272H, NPI707273H, NPI707274H, NPI707275H, NPI707276H, NPI707208H, NPI707214H, NPI707215H, NPI707216H, NPI707218H, NPI707219H, NPI707220H, NPI707221H, NPI707222H, NPI707223H, NPI707224H, NPI707225H, NPI707226H, NPI707227H, NPI707229H, NPI707230H, NPI707232H, NPI707233H, NPI707235H, NPI707236H, NPI707237H, NPI707238H, NPI707239H, NPI707240H, NPI707241H, NPI707243H, NPI707244H, NPI707245H, NPI707246H, NPI707184H, NPI707185H, NPI707187H, NPI707189H, NPI707190H, NPI707192H, NPI707193H, NPI707196H, NPI707199H, NPI707200H, NPI707201H, NPI707202H, NPI707203H, NPI707204H, NPI707205H, NPI707206H, NPI707207H, NPI707209H, NPI707210H, NPI707211H, NPI707212H, NPI707213H, NPI707161H, NPI707162H, NPI707163H, NPI707165H, NPI707166H, NPI707167H, NPI707168H, NPI707170H, NPI707171H, NPI707172H, NPI707175H, NPI707177H, NPI707178H, NPI707181H, NPI707131H, NPI707134H, NPI707137H, NPI707138H, NPI707139H, NPI707140H, NPI707141H, NPI707142H, NPI707143H, NPI707144H, NPI707145H, NPI707146H, NPI707148H, NPI707149H, NPI707150H, NPI707151H, NPI707156H, NPI707157H, NPI707159H, NPI707160H, NPI707103H, NPI707104H, NPI707105H, NPI707106H, NPI707107H, NPI707109H, NPI707110H, NPI707111H, NPI707112H, NPI707114H, NPI707115H, NPI707116H, NPI707117H, NPI707119H, NPI707121H, NPI707122H, NPI707123H, NPI707124H, NPI707126H, NPI707127H, NPI707129H, NPI707130H, NPI707135H, NPI707136H, NPI707084H, NPI707085H, NPI707086H, NPI707089H, NPI707092H, NPI707094H, NPI707095H, NPI707096H, NPI707097H, NPI707098H, NPI707099H, NPI707100H, NPI707102H, NPI707045H, NPI707050H, NPI707053H, NPI707054H, NPI707055H, NPI707056H, NPI707057H, NPI707058H, NPI707059H, NPI707061H, NPI707062H, NPI707063H, NPI707065H, NPI707066H, NPI707069H, NPI707070H, NPI707072H, NPI707073H, NPI707074H, NPI707075H, NPI707076H, NPI707077H, NPI707078H, NPI707080H, NPI707081H, NPI707082H, NPI707083H, NPI707020H, NPI707025H, NPI707026H, NPI707027H, NPI707028H, NPI707029H, NPI707030H, NPI707031H, NPI707032H, NPI707034H, NPI707035H, NPI707036H, NPI707037H, NPI707038H, NPI707039H, NPI707041H, NPI707042H, NPI707043H, NPI707046H, NPI707047H, NPI707048H, NPI707051H, NPI707052H, NPI706993H, NPI706994H, NPI706995H, NPI706996H, NPI706997H, NPI706998H, NPI706999H, NPI707002H, NPI707003H, NPI707004H, NPI707005H, NPI707006H, NPI707007H, NPI707008H, NPI707011H, NPI707012H, NPI707013H, NPI707014H, NPI707015H, NPI707016H, NPI707017H, NPI70701...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, India, Japan, Korea, Republic Of, Argentina, Brazil, Colombia, Thailand, and Hong Kong.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 5, 2022
Recall initiation date: Oct 19, 2021
Center classification date: Dec 27, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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