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U.S. Department of Health and Human Services

Class 2 Device Recall Maximo II CRT

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 Class 2 Device Recall Maximo II CRT see related information
Date Posted January 28, 2009
Recall Status1 Terminated on May 07, 2011
Recall Number Z-0667-2009
Recall Event ID 50137
PMA Number P010031 
Product Classification implantable pacemaker defibrillator - Product Code NIK
Product Maximo II CRT D284TRK, for ventricular pacing and defibrillation.
Code Information Lot Serial No
PZP600096S
PZP600610S
PZP600608S
PZP600546S
PZP600149S
PZP600569S
PZP600587S
PZP600589S
PZP600612S
PZP600450S
PZP600557S
PZP600193S
PZP600558S
PZP600559S
PZP600531S
PZP600533S
PZP600534S
PZP600535S
PZP600536S
PZP600199S
PZP600215S
PZP600473S
PZP600474S
PZP600475S
PZP600476S
PZP600477S
PZP600478S
PZP600479S
PZP600480S
PZP600607S
PZP600513S
PZP600514S
PZP600515S
PZP600516S
PZP600530S
PZP600092S
PZP600093S
PZP600562S
PZP600571S
PZP600609S
PZP600596S
PZP600166S
PZP600467S
PZP600529S
PZP600638S
PZP600134S
PZP600135S
PZP600172S
PZP600133S
PZP600509S
PZP600128S
PZP600196S
PZP600103S
PZP600111S
PZP600140S
PZP600142S
PZP600169S
PZP600527S
PZP600611S
PZP600636S
PZP600656S
PZP600614S
PZP600090S
PZP600141S
PZP600195S
PZP600137S
PZP600089S
PZP600112S
PZP600178S
PZP600127S
PZP600173S
PZP600211S
PZP600213S
PZP600511S
PZP600524S
PZP600577S
PZP600542S
PZP600091S
PZP600154S
PZP600174S
PZP600466S
PZP600177S
PZP600454S
PZP600455S
PZP600456S
PZP600457S
PZP600458S
PZP600459S
PZP600462S
PZP600463S
PZP600464S
PZP600465S
PZP600543S
PZP600552S
PZP600434S
PZP600510S
PZP600438S
PZP600439S
PZP600584S
PZP600221S
PZP600521S
PZP600180S
PZP600544S
PZP600604S
PZP600605S
PZP600606S
PZP600436S
PZP600517S
PZP600588S
PZP600113S
PZP600114S
PZP600115S
PZP600116S
PZP600117S
PZP600118S
PZP600119S
PZP600120S
PZP600121S
PZP600122S
PZP600097S
PZP600098S
PZP600099S
PZP600100S
PZP600101S
PZP600163S
PZP600164S
PZP600165S
PZP600448S
PZP600197S
PZP600200S
PZP600202S
PZP600203S
PZP600204S
PZP600205S
PZP600206S
PZP600207S
PZP600208S
PZP600209S
PZP600210S
PZP600136S
PZP600550S
PZP600637S
PZP600568S
PZP600109S
PZP600586S
PZP600159S
PZP600198S
PZP600160S
PZP600176S
PZP600161S
PZP600581S
PZP600582S
PZP600132S
PZP600108S
PZP600168S
PZP600170S
PZP600214S
PZP600512S
PZP600526S
PZP600545S
PZP600191S
PZP600192S
PZP600566S
PZP600567S
PZP600110S
PZP600528S
PZP600634S
PZP600155S
PZP600126S
PZP600129S
PZP600130S
PZP600131S
PZP600148S
PZP600123S
PZP600124S
PZP600171S
PZP600508S
PZP600158S
PZP600105S
PZP600153S
PZP600095S
PZP600094S
PZP600167S
PZP600212S
PZP600547S
PZP600538S
PZP600216S
PZP600217S
PZP600435S
PZP600162S
PZP600641S
PZP600146S
PZP600532S
PZP600592S
PZP600593S
PZP600594S
PZP600595S
PZP600143S
PZP600144S
PZP600555S
PZP600556S
PZP600618S
PZP600620S
PZP600506S
PZP600507S
PZP600657S
PZP600560S
PZP600561S
PZP600646S
PZP600649S
PZP600654S
PZP600107S
PZP600104S
PZP600147S
PZP600615S
PZP600617S
PZP600537S
PZP600598S
PZP600102S
PZP600194S
PZP600583S
PZP600157S
PZP600175S
PZP600087S
PZP600088S
PZP600444S
PZP600575S
PZP600576S
PZP600151S
PZP600106S
PZP600525S
PZP600471S
PZP600472S
PZP600599S
PZP600231S
PZP600232S
PZP600520S
PZP600226S
PZP600453S
PZP600541S
PZP600229S
PZP600230S
PZP600522S
PZP600523S
PZP600432S
PZP600433S
PZP600623S
PZP600624S
PZP600223S
PZP600585S
PZP600228S
PZP600653S
PZP600225S
PZP600179S
PZP600182S
PZP600183S
PZP600184S
PZP600185S
PZP600186S
PZP600188S
PZP600190S
PZP600218S
PZP600219S
PZP600222S
PZP600452S
PZP600629S
PZP600632S
PZP600437S
PZP600539S
PZP600224S
PZP600573S
PZP600574S
PZP600564S
PZP600565S
PZP600578S
PZP600579S
PZP600481S
PZP600482S
PZP600483S
PZP600484S
PZP600442S
PZP600621S
PZP600622S
PZP600580S
PZP600551S
PZP600644S
PZP600645S
PZP600468S
PZP600469S
PZP600470S
PZP600540S
PZP600655S
PZP600572S
PZP600625S
PZP600553S
PZP600554S
PZP600440S
PZP600626S
PZP600628S
PZP600630S
PZP600631S
PZP600150S
PZP600152S
PZP600548S
PZP600549S
PZP600570S
PZP600633S
PZP600518S
PZP600597S
PZP600145S
PZP600563S
PZP600139S
and PZP600643S.
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St Ne
Mounds View MN 55112-4391
763-514-4000
For Additional Information Contact
763-526-0000
Manufacturer Reason
for Recall
Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm
FDA Determined
Cause 2
Process design
Action A Medtronic Inc. letter dated July 30, 2008 was sent to Physicians. The letter described the product and problem. The letter advised to contact Technical Services for specific questions regarding the care of patients or how to program the Maximo II devices. The letter instructed to collect and hold all non-implanted Maximo II devices and that a Medtronic Representative will contact the doctor to make arrangements to update the programmer 2090.
Quantity in Commerce 313
Distribution No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIK and Original Applicant = MEDTRONIC INC.
PMAs with Product Code = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = NIK and Original Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = NIK and Original Applicant = MEDTRONIC, INC.
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