FDA-Device2016-04-06Class II
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Medtronic Inc.
Hazard
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
Sold states
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, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates and United Kingdom.
Affected count
189,009
Manufactured in
8200 Coral Sea St Ne, N/A, Saint Paul, MN, United States
Products
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1249-2016Don't want to check this manually?
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