Medtronic Recalls Reveal LINQ Cardiac Monitor Due to Algorithm Sensitivity Issue
Medtronic is recalling Reveal LINQ insertable cardiac monitors because an algorithm issue may trigger replacement alerts prematurely. The device battery and data collection capabilities remain functional.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that battery capacity is not affected and the device continues to function for data collection, indicating a low-risk software/algorithm issue rather than a physical safety hazard.
Plain-English summary
Medtronic Inc. is recalling the Reveal LINQ insertable cardiac monitor, Model LNQ11, due to an identified issue with the sensitivity of an algorithm used in the device. This issue may cause the Recommended Replacement Time (RRT) alert to trigger prematurely in some units. The recall affects 189,009 devices distributed worldwide, including the United States and numerous international markets.
The source text clarifies that the battery capacity of the devices is not affected by this algorithm issue. The devices will continue to support data collection and manual data transmissions. Medtronic continues to manufacture and distribute Reveal LINQ devices.
Patients with these devices should contact their healthcare provider or Medtronic for guidance on the premature RRT alerts. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Cardiac Monitor
- Affected units
- 189,009
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 (1)
- All Reveal LINQ ICM
Distribution
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