Recall Z-1605-2016— Medtronic Inc., Cardiac Rhythm and Heart Failure

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, initiated 2016-03-31, terminated 2017-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connection or an internet connection.. Reason: A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select cou.

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure

Classification

Class II

Status

Terminated

Initiated

2016-03-31

Terminated

2017-09-25

Firm location

Mounds View, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.