Medtronic Insertable Cardiac Monitor May Fail to Record Heart Rhythms
Medtronic recalled 64,739 ICM LNQ22 LINQ II insertable cardiac monitors due to potential amplified noise or signal reduction that may interfere with heart rhythm recordings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a cardiac monitoring device with risk-of-harm potential. No illnesses or injuries have been reported, but failure to properly record heart rhythms in an implanted cardiac monitor could result in missed detection of serious cardiac events in patients who depend on this device for monitoring.
Plain-English summary
Medtronic Inc. is recalling approximately 64,739 ICM LNQ22 LINQ II insertable cardiac monitors distributed in the United States and internationally. The recalled devices may experience amplified noise and/or signal reduction that could interfere with proper recording of heart rhythms. This type of noise pattern differs from occasional interference caused by device position changes, patient activity, or external electromagnetic interference.
Patients with these implanted monitors should contact their healthcare provider to discuss any concerns and determine appropriate follow-up. Patients should not discontinue use of their devices without consulting their physician first. Medtronic is coordinating with healthcare providers and regulatory authorities on this issue.
The recalled product
- Product
- ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
- Manufacturer
- Medtronic Inc.
- Affected units
- 64,739
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00763000060374
- Serial Numbers: RLB088215G
- RLB088216G
- RLB088218G
- RLB091019G
- RLB034146G
- RLB087479G
- RLB127232G
- RLB096039G
- RLB086587G
- RLB086621G
- RLB088233G
- RLB088236G
- RLB088253G
- RLB123314G
- RLB043944G
- RLB043960G
- RLB064996G
- RLB132967G
- RLB100312G
Distribution
Distributed in 1 state:
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