Aveir Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Leadless Pacemaker · First cleared Mar 2022 · 16 device variants grouped

Total Reports

4,771

Reports (30d)

226

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Increasing trendcriticalDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighIncreasing trendcriticalDisproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Feb 15, 2025 · Open, Classified

Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

Class II

Nov 21, 2024 · Open, Classified

Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

Class II

Feb 5, 2024 · Open, Classified

Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

Evidence

Related research

Comparative Performance, Procedural Characteristics and Safety of Micra Versus Aveir Leadless Pacemakers: Systematic Review.

Soleimani H, et al. · 2026

Leadless Versus Transvenous Single-Chamber Ventricular Pacemakers: Real-World Evidence From Aveir VR Coverage With Evidence Development Study.

Ip JE, et al. · 2025

Jugular Journeys: A Novel Approach for AVEIR Leadless Pacemaker Implantation

Shmaila Saleem‐Talib, et al. · Pacing and Clinical Electrophysiology · 2026

Safety and Efficacy of Aveir Leadless Pacemaker in Chinese Patients.

Zheng W, et al. · 2026

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.