Aveir Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Leadless Pacemaker · First cleared Mar 2022 · 20 device variants grouped
Total Reports
5,909
Reports (30d)
308
Active Signals
6
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Dislodgement During Implant
ventricle leadless, rvlp, right ventricle, pacemaker rvlp, ralp
70
reports
Device Dislodgement with Helix Stretching
pacemaker implant, implanted resolve, resolve event, event patient, stable condition
65
reports
Oversensing Episodes During Follow-Up
intervention performed, battery, changes, clinic follow, intervention
55
reports
Loss of Capture Leading to Explant
resolve event, event patient, increased, resolve, pacemaker exhibited
54
reports
Capture Failure During Implant Procedure
procedure implant, pacemaker implant, clinic aveir, aveir leadless, alternate
48
reports
Inability to Separate from Delivery Catheter
procedure surgery, condition patient, stable condition, procedure procedure, presented implant
46
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
May 12, 2026 · Open, Classified
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
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.
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.
Feb 5, 2024 · Open, Classified
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Evidence
Related research
Adverse events associated with Aveir<sup>TM</sup> VR leadless pacemaker: A Food and Drug Administration MAUDE database study
Jalaj Garg, et al. · Journal of Cardiovascular Electrophysiology · 2023
Device dislodgement and embolization associated with a new leadless pacemaker
Ali Bahbah, et al. · Journal of Cardiovascular Electrophysiology · 2024
One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker
Reinoud E. Knops, et al. · Circulation Arrhythmia and Electrophysiology · 2025
Comparative Performance, Procedural Characteristics and Safety of Micra Versus Aveir Leadless Pacemakers: Systematic Review.
Soleimani H, et al. · Pacing and clinical electrophysiology : PACE · 2026
A Dual-Chamber Leadless Pacemaker
Reinoud E. Knops, et al. · New England Journal of Medicine · 2023
Citations indexed from PubMed.
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