Aveir Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Leadless Pacemaker · First cleared Mar 2022 · 16 device variants grouped
Total Reports
5,284
Reports (30d)
219
Active Signals
9
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Separation Failure and Dislodgement
ventricular leadless, condition, leadless pacemaker, patient stable, patient presented
404
reports
Pericardial Effusion from Perforation
leadless pacemaker, pericardial effusion, perforation, effusion, pericardial
41
reports
Capture Failure During Implant Procedure
leadless pacemaker, presented clinic, pacemaker implant, aveir leadless, aveir
26
reports
Cardiac Tamponade During Implant
cardiac, tamponade, procedure procedure, presented implant, patient presented
25
reports
Helix Separation During Initial Implant
initial implant, stable procedure, leadless pacemaker, alp, atrial leadless
21
reports
Post-Implant Infection at Site
patient consequences, consequences, patient condition, infection, condition stable
13
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.
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