Icd-dr Ddbb1d4 Evera XT Is1/df4 US recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN 00643169720374, Lot Serial Numbers: BWB231977H, BWB232204H, BWB231981H, BWB231888H, BWB232232H, BWB232076H, BWB231876H, BWB231908H, BWB231979H, BWB232244H, BWB232310H, BWB231918H, BWB232114H, BWB231867H, BWB232361H, BWB231879H, BWB231847H, BWB232311H, BWB232048H, BWB231915H, BWB232272H, BWB232281H, BWB232164H, BWB232142H, BWB232316H, BWB232027H, BWB232321H, BWB231976H, BWB232046H, BWB232357H, BWB232185H, BWB232233H, BWB232334H, BWB232378H, BWB232411H, BWB232049H, BWB232218H, BWB232097H, BWB232326H, BWB232156H, BWB231855H, BWB231858H, BWB232032H, BWB232106H, BWB232015H, BWB232260H, BWB232284H, BWB232328H, BWB232059H, BWB232018H, BWB232037H, BWB232043H, BWB232092H, BWB232112H, BWB232125H, BWB232144H, BWB232175H, BWB232179H, BWB232181H, BWB232190H, BWB232216H, BWB232237H, BWB232340H, BWB232369H, BWB232410H, BWB232414H, BWB231927H, BWB232056H, BWB232071H, BWB232087H, BWB232121H, BWB232250H, BWB232403H, BWB232039H, BWB232123H, BWB232124H, BWB231865H, BWB232128H, BWB232152H, BWB231939H, BWB231999H, BWB232050H, BWB232217H, BWB232298H, BWB232368H, BWB232395H, BWB232222H, BWB232174H, BWB231916H, BWB231963H, BWB231965H, BWB231968H, BWB232084H, BWB232154H, BWB232320H, BWB232393H, BWB232396H, BWB232399H, BWB232400H, BWB232402H, BWB232413H, BWB232243H, BWB232322H, BWB231473H, BWB232183H, BWB232247H, BWB231989H, BWB232256H, BWB232132H, BWB232273H, BWB232274H, BWB232283H, BWB231932H, BWB232089H, BWB232208H, BWB231875H, BWB232269H, BWB232367H, BWB232407H, BWB232065H, BWB232069H, BWB231904H, BWB231985H, BWB232230H, BWB232355H, BWB232286H, BWB231929H, BWB232226H, BWB232329H, BWB231860H, BWB231881H, BWB231882H, BWB231885H, BWB232215H, BWB232381H, BWB232385H, BWB231938H, BWB232016H, BWB232148H, BWB232091H, BWB231852H, BWB232165H, BWB232220H, BWB232346H, BWB232302H, BWB232304H, BWB232341H, BWB232314H, BWB231984H, BWB232044H, BWB232105H, BWB232109H, BWB231907H, BWB232082H, BWB232201H, BWB232206H, BWB231919H, BWB231920H, BWB231849H, BWB232126H, BWB232191H, BWB232330H, BWB232349H, BWB231923H, BWB232014H, BWB232255H, BWB232242H, BWB232168H, BWB232213H, BWB232096H, BWB232107H, BWB232307H, BWB232387H, BWB232389H, BWB232404H, BWB231937H, BWB231949H, BWB231954H, BWB231967H, BWB232019H, BWB231910H, BWB231991H, BWB232239H, BWB232291H, BWB232282H, BWB232386H, BWB231952H, BWB232033H, BWB232158H, BWB232205H, BWB232173H, BWB232268H, BWB232122H, BWB231897H, BWB231912H, BWB232134H, BWB232324H, BWB232360H, BWB232401H, BWB232405H, BWB232406H, BWB231986H, BWB231933H, BWB231909H, BWB232294H, BWB231996H, BWB231880H, BWB232180H, BWB232067H, BWB232047H, BWB231859H, BWB231866H, BWB232068H, BWB232240H, BWB232245H, BWB231943H, BWB231959H, BWB232225H, BWB231911H, BWB231946H, BWB232022H, BWB232052H, BWB232195H, BWB232030H, BWB232231H, BWB232267H, BWB231474H, BWB232301H, BWB232364H, BWB232246H, BWB231862H, BWB231877H, BWB231886H, BWB231960H, BWB232151H, BWB232241H, BWB232351H, BWB232058H, BWB232117H, BWB232199H, BWB232136H, BWB231856H, BWB232147H, BWB232264H, BWB231988H, BWB232021H, BWB232090H, BWB232344H, BWB231873H, BWB232026H, BWB231869H, BWB232229H, BWB232166H, BWB232289H, BWB231950H, BWB231978H, BWB231962H, BWB232077H, BWB231992H, BWB232315H, BWB232374H, BWB231958H, BWB232011H, BWB232036H, BWB232137H, BWB231924H, BWB232198H, BWB232279H, BWB232300H, BWB232408H, BWB232024H, BWB232031H, BWB232062H, BWB232337H, BWB231476H, BWB232029H, BWB232127H, BWB232234H, BWB232317H, BWB231917H, BWB232161H, BWB231906H, BWB231964H, BWB231975H, BWB232045H, BWB232066H, BWB232412H, BWB231475H, BWB231995H, BWB232295H, BWB231861H, BWB231895H, BWB231901H, BWB231914H, BWB231957H, BWB232010H, BWB232025H, BWB232042H, BWB232051H, BWB232054H, BWB232079H, BWB232088H, BWB232100H, BWB232101H, BWB232110H, BWB232182H, BWB232252H, BWB232253H, BWB232259H, BWB232275H, BWB232288H, BWB232350H, BWB232365H, BWB232139H, BWB232167H, BWB231884H, BWB231892H, BWB231899H, BWB231900H, BWB232063H, BWB231982H, BWB232017H, BWB231961H, BWB232211H, BWB232353H, BWB232115H, BWB232189H, BWB231913H, BWB232099H, BWB231941H, BWB232312H, BWB231973H, BWB231987H, BWB232347H, BWB231903H, BWB231936H, BWB231953H, BWB232006H, BWB232040H, BWB232098H, BWB232118H, BWB232157H, BWB232177H, BWB232249H, BWB232261H, BWB232331H, BWB232345H, BWB232363H, BWB231894H, BWB231945H, BWB232176H, BWB232409H, BWB231930H, BWB231931H, BWB232129H, BWB232325H, BWB231872H, BWB232305H, BWB232041H, BWB232075H, BWB231868H, BWB231898H, BWB231905H, BWB231942H, BWB231974H, BWB231983H, BWB232023H, BWB232103H, BWB232104H, BWB232170H, BWB232196H, BWB232197H, BWB232227H, BWB232248H, BWB232254H, BWB232262H, BWB232263H, BWB232265H, BWB232278H, BWB232287H, BWB232292H, BWB232296H, BWB232297H, BWB232303H, BWB232318H, BWB232338H, BWB232348H, BWB232352H, BWB232359H, BWB232178H, BWB231971H, BWB231972H; GTIN 00763000059699, Lot Serial Numbers: BWB600022S, BWB600096S, BWB600123S, BWB600095S, BWB600107S, BWB600069S, BWB600221S, BWB600141S, BWB600101S, BWB600028S, BWB600068S, BWB600218S, BWB600224S, BWB600045S, BWB600092S, BWB600046S, BWB600031S, BWB600033S, BWB600035S, BWB600036S, BWB600037S, BWB600038S, BWB600110S, BWB600213S, BWB600049S, BWB600061S, BWB600048S, BWB600064S, BWB600177S, BWB600127S, BWB600132S, BWB600126S, BWB600144S, BWB600216S, BWB600024S, BWB600025S, BWB600082S, BWB600214S, BWB600215S, BWB600055S, BWB600137S, BWB600077S, BWB600174S, BWB600210S, BWB600062S, BWB600013S, BWB600166S, BWB600148S, BWB600014S, BWB600015S, BWB600034S, BWB600052S, BWB600087S, BWB600172S, BWB600053S, BWB600054S, BWB600071S, BWB600078S, BWB600233S, BWB600059S, BWB600089S, BWB600105S, BWB600106S, BWB600133S, BWB600040S, BWB600223S, BWB600050S, BWB600131S, BWB600227S, BWB600129S, BWB600211S, BWB600097S, BWB600098S, BWB600099S, BWB600136S, BWB600138S, BWB600139S, BWB600163S, BWB600051S, BWB600070S, BWB600080S, BWB600128S, BWB600130S, BWB600152S, BWB600065S, BWB600016S, BWB600212S, BWB600188S, BWB600198S, BWB600109S, BWB600019S, BWB600020S, BWB600116S, BWB600118S, BWB600153S, BWB600155S, BWB600156S, BWB600157S, BWB600160S, BWB600164S, BWB600165S, BWB600169S, BWB600173S, BWB600032S, BWB600170S, BWB600217S, BWB600142S, BWB600154S, BWB600112S, BWB600230S, BWB600073S, BWB600026S, BWB600076S, BWB600023S, BWB600228S, BWB600041S, BWB600225S, BWB600200S, BWB600201S, BWB600202S, BWB600203S, BWB600206S, BWB600209S, BWB600234S, BWB600207S, BWB600181S, BWB600182S, BWB600184S, BWB600186S, BWB600193S,

Product

ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators

Recalling firm

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

Quantity

522 units

Distribution

US Nationwide - Worldwide Distribution

Recall date

June 28, 2023

Classification

Class I

Status

Ongoing

Agency

FDA (device)