Medtronic AccuRhythm AI misses abnormal rhythms in LINQ monitors, per FDA and Reuters
Between 2021 and 2025, at least 16 FDA adverse event reports alleged that Medtronic's AccuRhythm AI in LINQ monitors failed to detect abnormal heart rhythms. Medtronic said it reviewed the cases and found only one missed abnormal event, attributing others to data display issues or user confusion; no patient harm was reported.
The AI algorithms in Medtronic’s LINQ monitors allegedly failed to recognize abnormal rhythms, with at least 16 reports filed to the FDA.
Key facts
- What
- Between 2021 and 2025, at least 16 FDA adverse event reports alleged that Medtronic's AccuRhythm AI in LINQ monitors failed to detect abnormal heart rhythms.
- Incident date
- Jan 1, 2021
- Who
- Medtronic
- Failure mode
- Hallucination
- AI surface
- Agentic Workflow
- Severity
- Low
What happened
At least 16 FDA MAUDE adverse event reports were filed between 2021 and October 2025 asserting that Medtronic's AccuRhythm AI in LINQ monitors failed to recognize abnormal rhythms or pauses. Medtronic reviewed the 16 episodes and asserted that only one abnormal heart-rhythm event was missed, attributing the rest to data display problems or user confusion, with no patient harm reported.
What broke inside the model
- 01 · TriggerA user asks for a fact, a citation, or a figure.
- 02 · Model stepThe model writes a fluent, confident answer.
- 03 · Control gapNothing ties the claim back to a real source.
- 04 · FailureA fabricated fact ships as if it were verified.
- 05 · ConsequenceThe false claim reaches a customer, a court, or the public.
Confidence holds, and even spikes, as the claim detaches from any source.
The deep learning algorithms designed to identify abnormal heart rhythms reportedly failed to trigger alerts for certain cardiac events, leading to misclassification or non-detection of arrhythmias. Medtronic attributed many reports to data display issues or user confusion rather than the AI itself.
What it cost
Sources
Cite this entry
https://failureindex.ai/failures/medtronic-accurhythm-misses-abnormal-rhythms-linqAI Failure Index. "Medtronic AccuRhythm AI misses abnormal rhythms in LINQ monitors, per FDA and Reuters" (FI-0258). Realm Labs. https://failureindex.ai/failures/medtronic-accurhythm-misses-abnormal-rhythms-linq (indexed Jun 5, 2026).Data fields CC-BY 4.0, prose citation permitted. Incident ID FI-0258. Full dataset at /data.
Note from Realm Labs, the Index steward
How Realm would have caught this
- Prism
- OmniGuard
- AI Detection & Response (AIDR)
A runtime layer that watches the model's internal state can flag the moment a model commits to a claim it has no support for, and hold or reroute the response before it reaches a user. Realm reads those signals in real time rather than grading the transcript after the fact.