Aveir Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Leadless Pacemaker · First cleared Mar 2022 · 22 device variants grouped
Total Reports
6,213
Reports (30d)
255
Active Signals
9
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
High Capture Threshold at Follow-Up
vlp, stable procedure, battery, alp, interrogation
86
reports
Delivery Catheter Separation Failure
procedure implant, pacemaker implant, clinic aveir, aveir leadless, alternate
64
reports
Dislodgement Found via X-Ray
pulmonary, ray, replaced patient, dislodgement, explanted replaced
58
reports
Capture Failure During Device Fixation
ventricular leadless, procedure surgery, condition patient, stable condition, presented implant
41
reports
High Capture Threshold Without Intervention
resolve event, resolve, right ventricular, capture threshold, threshold
40
reports
Delivery Catheter Release Difficulty
ventricle leadless, rvlp, right ventricle, procedure right, pacemaker rvlp
38
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
Helix fracture during atrial leadless pacemaker explantation
Ratika Parkash, et al. · HeartRhythm Case Reports · 2026
Double-Snare Retrieval and Mapping-Guided Reimplantation of a Dislodged Atrial Leadless Pacemaker
Sue-Ping Chang, et al. · JACC Case Reports · 2026
Percutaneous retrieval of embolized atrial leadless pacemakers: Early multicenter experience
Syed M. Zaidi, et al. · Heart Rhythm · 2026
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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