• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Maximo II DR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Medtronic Maximo II DR
see related information
Date Posted January 28, 2009
Recall Status1 Open
Recall Number Z-0665-2009
Recall Event ID 50137
Premarket Approval
PMA Number
P980016
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation.
Code Information Lot Serial No PZM600131S PZM600054S PZM600616S PZM600617S PZM600620S PZM600615S PZM600523S PZM600111S PZM600213S PZM600502S PZM600595S PZM600600S PZM600277S PZM600078S PZM600581S PZM600582S PZM600597S PZM600602S PZM600530S PZM600108S PZM600495S PZM600497S PZM600498S PZM600500S PZM600501S PZM600151S PZM600152S PZM600153S PZM600446S PZM600447S PZM600448S PZM600264S PZM600278S PZM600469S PZM600094S PZM600401S PZM600052S PZM600053S PZM600517S PZM600621S PZM600622S PZM600233S PZM600539S PZM600129S PZM600130S PZM600132S PZM600160S PZM600162S PZM600207S PZM600208S PZM600138S PZM600140S PZM600145S PZM600146S PZM600148S PZM600156S PZM600198S PZM600056S PZM600092S PZM600104S PZM600105S PZM600147S PZM600168S PZM600252S PZM600051S PZM600199S PZM600057S PZM600273S PZM600075S PZM600232S PZM600472S PZM600049S PZM600203S PZM600276S PZM600071S PZM600143S PZM600098S PZM600110S PZM600167S PZM600101S PZM600109S PZM600126S PZM600150S PZM600491S PZM600492S PZM600080S PZM600081S PZM600281S PZM600282S PZM600283S PZM600284S PZM600285S PZM600286S PZM600287S PZM600288S PZM600289S PZM600290S PZM600184S PZM600192S PZM600245S PZM600180S PZM600262S PZM600526S PZM600643S PZM600473S PZM600186S PZM600189S PZM600243S PZM600266S PZM600247S PZM600254S PZM600556S PZM600557S PZM600558S PZM600559S PZM600560S PZM600561S PZM600562S PZM600563S PZM600584S PZM600586S PZM600112S PZM600544S PZM600599S PZM600486S PZM600405S PZM600406S PZM600407S PZM600408S PZM600409S PZM600410S PZM600411S PZM600412S PZM600413S PZM600414S PZM600415S PZM600416S PZM600417S PZM600418S PZM600419S PZM600420S PZM600421S PZM600422S PZM600423S PZM600424S PZM600425S PZM600426S PZM600427S PZM600428S PZM600429S PZM600430S PZM600431S PZM600432S PZM600433S PZM600434S PZM600435S PZM600436S PZM600437S PZM600438S PZM600439S PZM600440S PZM600441S PZM600442S PZM600443S PZM600444S PZM600445S PZM600059S PZM600060S PZM600061S PZM600062S PZM600063S PZM600064S PZM600065S PZM600066S PZM600135S PZM600136S PZM600137S PZM600116S PZM600117S PZM600118S PZM600119S PZM600120S PZM600121S PZM600122S PZM600123S PZM600124S PZM600125S PZM600079S PZM600206S PZM600578S PZM600215S PZM600216S PZM600217S PZM600218S PZM600219S PZM600220S PZM600221S PZM600222S PZM600223S PZM600224S PZM600265S PZM600083S PZM600470S PZM600528S PZM600533S PZM600640S PZM600577S PZM600076S PZM600594S PZM600241S PZM600242S PZM600272S PZM600274S PZM600573S PZM600574S PZM600576S PZM600161S PZM600163S PZM600234S PZM600133S PZM600134S PZM600193S PZM600194S PZM600090S PZM600509S PZM600072S PZM600142S PZM600173S PZM600623S PZM600624S PZM600482S PZM600196S PZM600197S PZM600535S PZM600536S PZM600067S PZM600068S PZM600077S PZM600490S PZM600190S PZM600611S PZM600612S PZM600084S PZM600087S PZM600088S PZM600089S PZM600231S PZM600201S PZM600202S PZM600141S PZM600471S PZM600546S PZM600235S PZM600236S PZM600048S PZM600128S PZM600550S PZM600551S PZM600073S PZM600085S PZM600055S PZM600158S PZM600251S PZM600165S PZM600280S PZM600070S PZM600170S PZM600204S PZM600097S PZM600545S PZM600058S PZM600166S PZM600587S PZM600512S PZM600513S PZM600291S PZM600292S PZM600293S PZM600107S PZM600510S PZM600050S PZM600149S PZM600102S PZM600238S PZM600240S PZM600598S PZM600601S PZM600086S PZM600091S PZM600596S PZM600099S PZM600100S PZM600093S PZM600155S PZM600157S PZM600159S PZM600253S PZM600171S PZM600590S PZM600493S PZM600074S PZM600209S PZM600580S PZM600494S PZM600069S PZM600200S PZM600144S PZM600154S PZM600047S PZM600095S PZM600275S PZM600547S PZM600225S PZM600113S PZM600613S PZM600614S PZM600542S PZM600237S PZM600402S PZM600403S PZM600404S PZM600514S PZM600515S PZM600258S PZM600259S PZM600487S PZM600248S PZM600279S PZM600508S PZM600256S PZM600257S PZM600608S PZM600609S PZM600488S PZM600489S PZM600261S PZM600263S PZM600641S PZM600642S PZM600270S PZM600516S PZM600589S PZM600592S PZM600255S PZM600249S PZM600169S PZM600172S PZM600174S PZM600175S PZM600176S PZM600177S PZM600178S PZM600179S PZM600181S PZM600182S PZM600183S PZM600187S PZM600191S PZM600246S PZM600474S PZM600644S PZM600507S PZM600543S PZM600250S PZM600244S PZM600534S PZM600548S PZM600549S PZM600537S PZM600538S PZM600552S PZM600553S PZM600185S PZM600188S PZM600521S PZM600522S PZM600271S PZM600527S PZM600607S PZM600627S PZM600555S PZM600646S PZM600294S PZM600295S PZM600511S PZM600713S PZM600714S PZM600260S PZM600524S PZM600525S PZM600554S PZM600268S PZM600269S PZM600475S PZM600476S PZM600477S PZM600214S PZM600541S PZM600210S PZM600212S PZM600520S PZM600540S PZM600114S PZM600115S PZM600226S PZM600229S PZM600230S PZM600483S PZM600484S PZM600485S PZM600529S PZM600205S PZM600572S PZM600575S PZM600267S PZM600106S PZM600164S PZM600103S and PZM600645S.
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St Ne
Mounds View, Minnesota 55112-4391
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 419
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 = LWS and Applicant = MEDTRONIC INC.
PMAs with Product Code = LWS and Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Applicant = MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = LWS and Applicant = MEDTRONIC, INC.
-
-