Company: Medtronic Inc
Date of Enforcement Report 8/25//2010
Class ll:
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. Z-2209-2010
REASON
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letters dated 6/10/2010.
Manufacturer: Plexus Manufacturing Sdn. Bhd., Penang, Malaysia. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Australia and Canada
