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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Carelink Monitor Model 2490C

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 Class 2 Recall
Medtronic Carelink Monitor Model 2490C
see related information
Date Posted August 11, 2010
Recall Status1 Terminated on December 24, 2011
Recall Number Z-2209-2010
Recall Event ID 56118
Premarket Approval
PMA Number
P890003
Product Classification Pulse Generator, Permanent, Implantable - Product Code NVZ
Product Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The gathered heart device information is sent over a telephone line to the clinic using a toll-free number. The monitor can also send wireless heart device alerts to the clinic automatically.
Code Information Lot Serial No IJX061043P IJX061063P IJX067150P IJX067158P IJX067162P IJX013664P IJX013831P IJX014701P IJX014899P IJX015305P IJX015406P IJX015768P IJX062594P IJX062607P IJX062654P IJX062655P IJX062656P IJX062661P IJX062669P IJX062670P IJX062672P IJX062673P IJX062674P IJX062683P IJX062698P IJX062701P IJX062706P IJX062716P IJX062727P IJX062734P IJX062736P IJX062738P IJX062739P IJX062741P IJX062747P IJX062763P IJX062764P
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
Manufacturer Reason
for Recall
Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via CareLink. These monitors are now non-functional. No patient injuries have been reported as a result of this issue.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action Starting on 6/11/2010, Medtronic began sending Australian and Canadian consignees "Medical Device Recall" letters dated 6/10/2010. The letters describe the problem and product involved. The letters instructs consignees to order replacement monitors, notify affected patients, and instruct each patient to perform a manual transmission upon receipt of the new monitor. Medtronic will provide affected patients with a prepaid return kit to faciliate the return of the monitor to Medtronic. Australian consignees should contact Scott Dunlop at 61-7 3025-3547. Canadian consignees should contact Medtronic Patient Services at 1-800-268-5346.
Quantity in Commerce 37 Foreign, 0 Domestic
Distribution International Distribution Only: Australia and Canada.
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 = NVZ and Applicant = MEDTRONIC INC.
PMAs with Product Code = NVZ and Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = NVZ and Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = NVZ and Applicant = MEDTRONIC, INC.
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