Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328
Description: CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1769-2023 |
| Event ID | 92328 |
| Event Description | CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution |
| Quantity | 664 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 00643169837706, Lot Serial Numbers: RPW200770H, RPW200730H, RPW201054H, RPW200583H, RPW200593H, RPW200970H, RPW201002H, RPW201095H, RPW200917H, RPW201040H, RPW201026H, RPW200661H, RPW200981H, RPW200665H, RPW200741H, RPW200743H, RPW200908H, RPW200971H, RPW200600H, RPW200635H, RPW200638H, RPW200652H, RPW200657H, RPW200660H, RPW200761H, RPW200800H, RPW200803H, RPW200822H, RPW200827H, RPW200714H, RPW200809H, RPW200548H, RPW201023H, RPW201103H, RPW200575H, RPW200794H, RPW200807H, RPW200994H, RPW201055H, RPW200630H, RPW200659H, RPW200904H, RPW201079H, RPW201171H, RPW200578H, RPW200695H, RPW200621H, RPW201015H, RPW201084H, RPW201151H, RPW201153H, RPW200590H, RPW200938H, RPW200582H, RPW200847H, RPW200870H, RPW200683H, RPW200685H, RPW200754H, RPW200852H, RPW200585H, RPW200648H, RPW200669H, RPW200673H, RPW200721H, RPW200839H, RPW200879H, RPW200882H, RPW201041H, RPW201140H, RPW201161H, RPW200692H, RPW200863H, RPW200881H, RPW200969H, RPW201032H, RPW200553H, RPW200543H, RPW200595H, RPW200686H, RPW200698H, RPW200738H, RPW200750H, RPW200753H, RPW200804H, RPW200813H, RPW200838H, RPW200894H, RPW201133H, RPW200556H, RPW200855H, RPW200626H, RPW200646H, RPW200711H, RPW201080H, RPW200577H, RPW201088H, RPW200653H, RPW200605H, RPW200728H, RPW200889H, RPW200890H, RPW200964H, RPW200977H, RPW201012H, RPW201139H, RPW200552H, RPW200764H, RPW200833H, RPW200857H, RPW200858H, RPW200688H, RPW200561H, RPW200825H, RPW200625H, RPW200703H, RPW200746H, RPW200846H, RPW201108H, RPW200664H, RPW201129H, RPW201061H, RPW201051H, RPW200885H, RPW200900H, RPW200978H, RPW201009H, RPW201044H, RPW201059H, RPW201106H, RPW200636H, RPW200637H, RPW200808H, RPW200815H, RPW200895H, RPW200915H, RPW200944H, RPW200682H, RPW201046H, RPW201060H, RPW201071H, RPW201072H, RPW201078H, RPW201125H, RPW200572H, RPW201124H, RPW200837H, RPW200975H, RPW200662H, RPW200691H, RPW200720H, RPW200722H, RPW200897H, RPW200996H, RPW201107H, RPW201116H, RPW201134H, RPW200785H, RPW201005H, RPW201006H, RPW201030H, RPW201058H, RPW201075H, RPW200713H, RPW200551H, RPW200563H, RPW200610H, RPW200615H, RPW200841H, RPW200911H, RPW200965H, RPW200985H, RPW200744H, RPW200843H, RPW200880H, RPW201016H, RPW201019H, RPW201045H, RPW201067H, RPW201081H, RPW201090H, RPW201110H, RPW201121H, RPW200749H, RPW200811H, RPW200816H, RPW200886H, RPW200942H, RPW201068H, RPW201155H, RPW200566H, RPW200647H, RPW200780H, RPW200781H, RPW200707H, RPW201128H, RPW200599H, RPW200606H, RPW200640H, RPW200668H, RPW201037H, RPW201065H, RPW201118H, RPW201119H, RPW201154H, RPW200611H, RPW200616H, RPW200618H, RPW201039H, RPW201083H, RPW200851H, RPW200937H, RPW200999H, RPW201066H, RPW200717H, RPW200983H, RPW201105H, RPW200675H, RPW201163H, RPW200677H, RPW200678H, RPW200801H, RPW200574H, RPW200706H, RPW200919H, RPW200649H, RPW200748H, RPW200877H, RPW200878H, RPW200901H, RPW200542H, RPW201112H, RPW201166H, RPW201018H, RPW200998H, RPW201004H, RPW200701H, RPW201042H, RPW200671H, RPW201156H, RPW200562H, RPW200769H, RPW201152H, RPW201162H, RPW201123H, RPW201170H, RPW201013H, RPW201143H, RPW200910H, RPW200974H, RPW200632H, RPW200845H, RPW200991H, RPW200601H, RPW200676H, RPW200631H, RPW200933H, RPW201100H, RPW200798H, RPW200872H, RPW201077H, RPW201092H, RPW201127H, RPW201130H, RPW200580H, RPW200687H, RPW200724H, RPW200747H, RPW200818H, RPW200836H, RPW200888H, RPW200898H, RPW200859H, RPW201097H, RPW200883H, RPW201159H, RPW200776H, RPW201076H, RPW200544H, RPW200598H, RPW200980H, RPW201093H, RPW201094H, RPW201117H, RPW201157H, RPW201158H, RPW201149H, RPW200643H, RPW200760H, RPW200856H, RPW201000H, RPW201085H, RPW201137H, RPW200645H, RPW201142H, RPW201008H, RPW201074H, RPW201150H, RPW201148H, RPW201167H, RPW201114H, RPW201115H, RPW201126H, RPW201160H, RPW201165H, RPW200829H, RPW200992H, RPW201025H, RPW201062H, RPW201070H, RPW201091H, RPW200679H, RPW200710H, RPW200725H, RPW200873H, RPW200982H, RPW201001H, RPW201033H, RPW201063H, RPW201102H, RPW201113H, RPW200967H, RPW201073H, RPW200865H, RPW200987H, RPW201010H, RPW201021H, RPW201034H, RPW201049H, RPW201056H, RPW201064H, RPW201146H, RPW201069H, RPW200763H, RPW200799H, RPW201144H, RPW200830H, RPW200849H, RPW200990H, RPW201138H, RPW201168H, RPW201135H; GTIN 00763000060091, Lot Serial Numbers: RPW600177S, RPW600267S, RPW600059S, RPW600341S, RPW600418S, RPW600064S, RPW600173S, RPW600395S, RPW600018S, RPW600292S, RPW600381S, RPW600342S, RPW600352S, RPW600356S, RPW600317S, RPW600405S, RPW600306S, RPW600319S, RPW600273S, RPW600281S, RPW600146S, RPW600062S, RPW600041S, RPW600140S, RPW600162S, RPW600265S, RPW600307S, RPW600073S, RPW600068S, RPW600070S, RPW600074S, RPW600151S, RPW600175S, RPW600314S, RPW600030S, RPW600086S, RPW600123S, RPW600165S, RPW600023S, RPW600225S, RPW600275S, RPW600194S, RPW600339S, RPW600340S, RPW600017S, RPW600099S, RPW600348S, RPW600211S, RPW600268S, RPW600244S, RPW600313S, RPW600338S, RPW600355S, RPW600410S, RPW600076S, RPW600141S, RPW600163S, RPW600213S, RPW600094S, RPW600206S, RPW600087S, RPW600136S, RPW600214S, RPW600077S, RPW600126S, RPW600158S, RPW600012S, RPW600016S, RPW600075S, RPW600145S, RPW600167S, RPW600193S, RPW600223S, RPW600295S, RPW600198S, RPW600310S, RPW600336S, RPW600337S, RPW600385S, RPW600027S, RPW600048S, RPW600150S, RPW600152S, RPW600263S, RPW600035S, RPW600350S, RPW600230S, RPW600036S, RPW600039S, RPW600091S, RPW600111S, RPW600289S, RPW600232S, RPW600283S, RPW600284S, RPW600308S, RPW600377S, RPW600403S, RPW600093S, RPW600153S, RPW600164S, RPW600185S, RPW600192S, RPW600196S, RPW600201S, RPW600203S, RPW600204S, RPW600261S, RPW600375S, RPW600426S, RPW600376S, RPW600380S, RPW600055S, RPW600220S, RPW600229S, RPW600182S, RPW600113S, RPW600205S, RPW600218S, RPW600260S, RPW600384S, RPW600401S, RPW600245S, RPW600034S, RPW600037S, RPW600084S, RPW600019S, RPW600063S, RPW600117S, RPW600296S, RPW600345S, RPW600366S, RPW600102S, RPW600120S, RPW600122S, RPW600291S, RPW600421S, RPW600293S, RPW600367S, RPW600321S, RPW600368S, RPW600056S, RPW600060S, RPW600078S, RPW600096S, RPW600277S, RPW600396S, RPW600398S, RPW600161S, RPW600166S, RPW600195S, RPW600014S, RPW600202S, RPW600414S, RPW600316S, RPW600372S, RPW600379S, RPW600155S, RPW600159S, RPW600170S, RPW600190S, RPW600240S, RPW600269S, RPW600294S, RPW600420S, RPW600032S, RPW600252S, RPW600327S, RPW600329S, RPW600390S, RPW600393S, RPW600040S, RPW600044S, RPW600115S, RPW600142S, RPW600143S, RPW600197S, RPW600264S, RPW600278S, RPW600280S, RPW600386S, RPW600415S, RPW600028S, RPW600061S, RPW600103S, RPW600125S, RPW600138S, RPW600181S, RPW600189S, RPW600247S, RPW600248S, RPW600274S, RPW600156S, RPW600089S, RPW600236S, RPW600253S, RPW600259S, RPW600045S, RPW600257S, RPW600258S, RPW600276S, RPW600328S, RPW600100S, RPW600157S, RPW600422S, RPW600015S, RPW600043S, RPW600324S, RPW600330S, RPW600095S, RPW600118S, RPW600279S, RPW600304S, RPW600108S, RPW600237S, RPW600238S, RPW600239S, RPW600311S, RPW600013S, RPW600050S, RPW600169S, RPW600179S, RPW600226S, RPW600254S, RPW600382S, RPW600383S, RPW600144S, RPW600147S, RPW600148S, RPW600250S, RPW600290S, RPW600397S, RPW600022S, RPW600309S, RPW600399S, RPW600407S, RPW600413S, RPW600072S, RPW600092S, RPW600097S, RPW600112S, RPW600116S, RPW600131S, RPW600135S, RPW600137S, RPW600160S, RPW600417S, RPW600124S, RPW600010S, RPW600026S, RPW600083S, RPW600176S, RPW600256S, RPW600315S, RPW600371S, RPW600392S, RPW600020S, RPW600031S, RPW600057S, RPW600127S, RPW600217S, RPW600224S, RPW600234S, RPW600241S, RPW600266S, RPW600394S, RPW600312S, RPW600349S, RPW600362S, RPW600183S, RPW600210S, RPW600235S, RPW600404S, RPW600370S, RPW600047S, RPW600066S, RPW600119S, RPW600427S, RPW600297S, RPW600255S, RPW600180S, RPW600200S, RPW600025S, RPW600130S, RPW600243S, RPW600318S, RPW600325S, RPW600046S, RPW600049S, RPW600088S, RPW600098S, RPW600114S, RPW600154S, RPW600168S, RPW600171S, RPW600172S, RPW600174S, RPW600184S, RPW600215S, RPW600334S, RPW600134S, RPW600139S, RPW600121S, RPW600305S, RPW600302S, RPW600128S, RPW600149S, RPW600222S, RPW600231S, RPW600270S, RPW600271S, RPW600272S, RPW600262S, RPW600282S, RPW600186S, RPW600219S, RPW600347S, RPW600373S, RPW600251S, RPW600287S, RPW600288S, RPW600364S |
| Center Classification Date | 20230616 |
| Recall Initiation Date | 20230510 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
| Similar To |