StarClose SE Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Apr 2018 · 2 device variants grouped
Total Reports
993
Reports (30d)
5
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Suture Break During Arteriotomy Closure
provided arteriotomy, arteriotomy closure, prostyle, using prostyle, prostyle device
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database.
Johnson DT, et al. · Journal of vascular and interventional radiology : JVIR · 2013
Starclose SE® hemostasis after 6F direct antegrade superficial femoral artery access distal to the femoral head for peripheral endovascular procedures in obese patients.
Spiliopoulos S, et al. · Diagnostic and interventional radiology (Ankara, Turkey) · 2016
Angioseal VIP® vs. StarClose SE® closure devices: a comparative analysis in non-cardiological procedures.
Lucatelli P, et al. · The Journal of cardiovascular surgery · 2013
Safety and efficacy of StarClose SE Vascular Closure System in high-risk liver interventional oncology patients.
Gaba RC, et al. · The journal of vascular access · 2012
Safety and efficacy of arterial closure devices in an office-based angiosuite.
Dham S, et al. · Journal of vascular surgery · 2025
Citations indexed from PubMed.
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