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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 Initiated by Firm July 25, 2008
Date Posting Updated January 28, 2009
Recall Status1 Terminated 3 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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