Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls MEDTRONIC CARELINK 2090 programmer

Recall date

January 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0795-2019

FDA classification

Class II

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Sold / distributed

US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDTRONIC CARELINK 2090 programmer