Recall – Software error leads to RRT miscalculation

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

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