FDA-Device2023-12-06Class II
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Medtronic Inc.
Hazard
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.
Sold states
US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Macao, Malaysia, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
Affected count
64,739 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0421-2024Don't want to check this manually?
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