Medtronic Inc. recalls Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.

Recall date

February 23, 2016

Source

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

Recall number

Z-1249-2016

FDA classification

Class II

Brand / firm

Medtronic Inc.

Sold / distributed

Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia,…

Why it was recalled

Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal

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

What was recalled

Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.