Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Date of Enforcement Report: 2/1/2019
Class II
PRODUCT
MEDTRONIC CARELINK 2090 programmer
Recall Number: Z-0795-2019
REASON
There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN on 1/17/2019. Voluntary: Firm Initiated, recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
33,007 units
DISTRIBUTION
U.S. Nationwide and International