ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Reported: December 6, 2023 Initiated: November 3, 2023 #Z-0421-2024
Product Description
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.
Details
- Recalling Firm
- Medtronic Inc.
- Units Affected
- 64,739 units
- 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
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor. Recalled by Medtronic Inc.. Units affected: 64,739 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2023. Severity: Moderate. Recall number: Z-0421-2024.
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