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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Maximo II VR

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 Class 2 Device Recall Medtronic Maximo II VR see related information
Date Posted January 28, 2009
Recall Status1 Terminated on May 07, 2011
Recall Number Z-0666-2009
Recall Event ID 50137
PMA Number P980016 
Product Classification implantable pacemaker defibrillator - Product Code LWS
Product Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation.
Code Information ZN600356S
PZN600357S
PZN600358S
PZN600204S
PZN600205S
PZN600371S
PZN600395S
PZN600469S
PZN600387S
PZN600264S
PZN600342S
PZN600628S
PZN600629S
PZN600233S
PZN600368S
PZN600243S
PZN600244S
PZN600353S
PZN600382S
PZN600314S
PZN600315S
PZN600319S
PZN600384S
PZN600416S
PZN600192S
PZN600193S
PZN600311S
PZN600417S
PZN600443S
PZN600194S
PZN600309S
PZN600310S
PZN600124S
PZN600126S
PZN600289S
PZN600344S
PZN600343S
PZN600373S
PZN600178S
PZN600179S
PZN600242S
PZN600376S
PZN600089S
and PZN600449S.
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St Ne
Mounds View MN 55112-4391
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 376
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 Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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