Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328
Description: ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1822-2023 |
| Event ID | 92328 |
| Event Description | ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution |
| Quantity | 510 units |
| Recall Reason | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. |
| Device Classification | 20230628 |
| Device Code Info | GTIN 00763000178536, Lot Serial Numbers: RSG600215S, RSG600106S, RSG600196S, RSG600208S, RSG600223S, RSG600280S, RSG600125S, RSG600193S, RSG600006S, RSG600016S, RSG600123S, RSG600136S, RSG600573S, RSG600113S, RSG600249S, RSG600395S, RSG600579S, RSG600173S, RSG600111S, RSG600112S, RSG600116S, RSG600118S, RSG600130S, RSG600143S, RSG600175S, RSG600191S, RSG600205S, RSG600209S, RSG600272S, RSG600564S, RSG600167S, RSG600187S, RSG600077S, RSG600131S, RSG600145S, RSG600162S, RSG600245S, RSG600253S, RSG600512S, RSG600519S, RSG600037S, RSG600536S, RSG600544S, RSG600210S, RSG600643S, RSG600642S, RSG600122S, RSG600138S, RSG600174S, RSG600200S, RSG600225S, RSG600233S, RSG600585S, RSG600134S, RSG600168S, RSG600148S, RSG600132S, RSG600240S, RSG600055S, RSG600121S, RSG600179S, RSG600186S, RSG600158S, RSG600181S, RSG600219S, RSG600108S, RSG600164S, RSG600255S, RSG600511S, RSG600109S, RSG600110S, RSG600115S, RSG600117S, RSG600178S, RSG600250S, RSG600560S, RSG600083S, RSG600581S, RSG600639S, RSG600140S, RSG600232S, RSG600126S, RSG600141S, RSG600152S, RSG600166S, RSG600183S, RSG600204S, RSG600228S, RSG600242S, RSG600243S, RSG600246S, RSG600278S, RSG600114S, RSG600190S, RSG600201S, RSG600137S, RSG600157S, RSG600172S, RSG600171S, RSG600537S, RSG600185S, RSG600163S, RSG600546S, RSG600231S, RSG600144S, RSG600220S, RSG600107S, RSG600237S, RSG600554S, RSG600119S, RSG600520S, RSG600625S, RSG600627S; GTIN 00763000178543, Lot Serial Numbers: RSG600567S, RSG600684S, RSG600753S, RSG600654S, RSG600347S, RSG600349S, RSG600833S, RSG600842S, RSG600829S, RSG600700S, RSG600705S, RSG600730S, RSG600362S, RSG600868S, RSG600729S, RSG600803S, RSG600313S, RSG600584S, RSG600688S, RSG600827S, RSG600079S, RSG600306S, RSG600103S, RSG600105S, RSG600317S, RSG600474S, RSG600741S, RSG600379S, RSG600529S, RSG600656S, RSG600657S, RSG600674S, RSG600738S, RSG600330S, RSG600380S, RSG600063S, RSG600315S, RSG600316S, RSG600334S, RSG600335S, RSG600476S, RSG600572S, RSG600673S, RSG600332S, RSG600333S, RSG600619S, RSG600311S, RSG600444S, RSG600050S, RSG600070S, RSG600320S, RSG600652S, RSG600052S, RSG600327S, RSG600609S, RSG600582S, RSG600371S, RSG600319S, RSG600089S, RSG600477S, RSG600591S, RSG600039S, RSG600041S, RSG600053S, RSG600054S, RSG600057S, RSG600072S, RSG600324S, RSG600369S, RSG600383S, RSG600445S, RSG600455S, RSG600506S, RSG600571S, RSG600595S, RSG600599S, RSG600615S, RSG600630S, RSG600638S, RSG600739S, RSG600740S, RSG600743S, RSG600847S, RSG600851S, RSG600908S, RSG600909S, RSG600757S, RSG600760S, RSG600810S, RSG600814S, RSG600926S, RSG600927S, RSG600534S, RSG600568S, RSG600719S, RSG600761S, RSG600676S, RSG600481S, RSG600651S, RSG600325S, RSG600912S, RSG600742S, RSG600745S, RSG600746S, RSG600073S, RSG600087S, RSG600314S, RSG600322S, RSG600337S, RSG600363S, RSG600382S, RSG600569S, RSG600025S, RSG600368S, RSG600084S, RSG600007S, RSG600008S, RSG600009S, RSG600012S, RSG600013S, RSG600014S, RSG600023S, RSG600024S, RSG600026S, RSG600029S, RSG600042S, RSG600366S, RSG600377S, RSG600404S, RSG600458S, RSG600603S, RSG600680S, RSG600028S, RSG600708S, RSG600574S, RSG600398S, RSG600374S, RSG600040S, RSG600059S, RSG600074S, RSG600088S, RSG600098S, RSG600412S, RSG600018S, RSG600020S, RSG600033S, RSG600402S, RSG600060S, RSG600011S, RSG600022S, RSG600049S, RSG600367S, RSG600010S, RSG600058S, RSG600484S, RSG600043S, RSG600045S, RSG600397S, RSG600400S, RSG600661S, RSG600350S, RSG600351S, RSG600352S, RSG600354S, RSG600355S, RSG600357S, RSG600358S, RSG600359S, RSG600360S, RSG600361S, RSG600394S, RSG600414S, RSG600448S, RSG600451S, RSG600508S, RSG600522S, RSG600523S, RSG600524S, RSG600526S, RSG600543S, RSG600669S, RSG600655S, RSG600648S, RSG600852S, RSG600430S, RSG600431S, RSG600432S, RSG600469S, RSG600470S, RSG600471S, RSG600507S, RSG600527S, RSG600528S, RSG600530S, RSG600531S, RSG600541S, RSG600551S, RSG600415S, RSG600427S, RSG600428S, RSG600429S, RSG600439S, RSG600454S, RSG600461S, RSG600525S, RSG600550S, RSG600637S, RSG600722S, RSG600386S, RSG600387S, RSG600388S, RSG600389S, RSG600390S, RSG600391S, RSG600434S, RSG600440S, RSG600447S, RSG600449S, RSG600452S, RSG600459S, RSG600464S, RSG600478S, RSG600515S, RSG600538S, RSG600548S, RSG600711S, RSG600712S, RSG600859S, RSG600518S, RSG600547S, RSG600407S, RSG600408S, RSG600409S, RSG600410S, RSG600446S, RSG600517S, RSG600030S, RSG600031S, RSG600047S, RSG600065S, RSG600068S, RSG600075S, RSG600101S, RSG600370S, RSG600375S, RSG600399S, RSG600401S, RSG600403S, RSG600542S, RSG600575S, RSG600668S, RSG600457S, RSG600413S, RSG600561S, RSG600624S, RSG600683S, RSG600036S, RSG600305S, RSG600450S, RSG600587S, RSG600658S, RSG600348S, RSG600356S, RSG600365S, RSG600435S, RSG600628S, RSG600629S, RSG600640S, RSG600724S, RSG600066S, RSG600364S, RSG600532S, RSG600632S, RSG600736S, RSG600310S, RSG600017S, RSG600027S, RSG600376S, RSG600384S, RSG600405S, RSG600442S, RSG600056S, RSG600645S, RSG600671S, RSG600396S, RSG600417S, RSG600418S, RSG600419S, RSG600420S, RSG600421S, RSG600422S, RSG600423S, RSG600424S, RSG600425S, RSG600433S, RSG600436S, RSG600437S, RSG600438S, RSG600441S, RSG600453S, RSG600463S, RSG600521S, RSG600540S, RSG600555S, RSG600562S, RSG600617S, RSG600623S, RSG600636S, RSG600650S, RSG600653S, RSG600663S, RSG600665S, RSG600702S, RSG600703S, RSG600707S, RSG600725S, RSG600726S, RSG600749S, RSG600877S, RSG600392S, RSG600393S, RSG600583S, RSG600694S, RSG600695S, RSG600696S, RSG600385S, RSG600604S, RSG600482S, RSG600516S, RSG600533S, RSG600539S, RSG600545S, RSG600566S, RSG600594S, RSG600597S, RSG600601S, RSG600610S, RSG600612S, RSG600616S, RSG600620S, RSG600621S, RSG600626S, RSG600647S, RSG600666S, RSG600679S, RSG600689S, RSG600704S, RSG600706S, RSG600710S, RSG600715S, RSG600716S, RSG600717S, RSG600718S, RSG600723S, RSG600731S, RSG600732S, RSG600734S, RSG600735S, RSG600737S, RSG600750S, RSG600751S, RSG600752S, RSG600754S, RSG600764S, RSG600794S, RSG600796S, RSG600811S, RSG600824S, RSG600825S, RSG600826S, RSG600828S, RSG600830S, RSG600832S, RSG600834S, RSG600835S, RSG600836S, RSG600837S, RSG600839S, RSG600841S, RSG600843S, RSG600845S, RSG600849S, RSG600850S, RSG600854S, RSG600863S, RSG600865S, RSG600873S, RSG600874S, RSG600881S, RSG600910S, RSG600911S, RSG600913S, RSG600914S, RSG600535S, RSG600667S, RSG600744S, RSG600907S |
| Center Classification Date | 20230616 |
| Recall Initiation Date | 20230510 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
| Similar To |