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Medtronic Inc. recalls ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Recalled December 6, 2023 · FDA recall Z-0421-2024 · Medtronic
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. · FDA Class II
Units
64,739 units
Sold at
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
Description
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.
Product
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Manufacturer(s)
Medtronic Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →