RV LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
255
Reports (30d)
0
Active Signals
0
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Fracture / Ventricular Lead / Lead Explanted
lead explanted, fracture, voltage, explanted replaced, ventricular lead
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Oct 29, 2025 · Open, Classified
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Evidence
Related research
Subacute Apical RV Lead Microperforation in CRT Implantation
Ashesh Halder, et al. · JACC Case Reports · 2026
Apical Lead Position Increases the Risk of Right Ventricular Lead Perforation: A Retrospective Cohort Study
Yuji Manabe, et al. · Pacing and Clinical Electrophysiology · 2026
Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions
Tatyana Yevgenyevna Storozhenko, et al. · JACC. Clinical electrophysiology · 2025
RV lead placement – A forgotten cause of right heart failure
Muhammad Arslan Cheema, et al. · Annals of Medicine and Surgery · 2021
Citations indexed from PubMed.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,344 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 39,133 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,062 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,710 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,671 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data