FDA recall Z-0421-2024

Medtronic Inc. · Class II · device

Product

ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-11-03
Report date
2023-12-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0421-2024