Perclose ProStyle Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Aug 2022
Total Reports
19,655
Reports (30d)
112
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Suture Break During Knot Advancement
provided arteriotomy, arteriotomy closure, prostyle, using prostyle, prostyle device
46
reports
Suture Break During Pre-Close Technique
ablation, pre placed, prostyle, prostyle device, femoral vein
32
reports
Plunger Failure in Pre-Close Technique
pre close, using pre, pre placed, close technique, prostyle
25
reports
Device Breakage Before Use
prostyle, using prostyle, body, prostyle device, procedure reportedly
14
reports
Suture Failure to Capture Vessel
pre close, using pre, pre placed, close technique, prostyle
12
reports
Incomplete Retraction of Closure Device
provided arteriotomy, using pre, arteriotomy closure, prostyle devices, prostyle
9
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
Vessel wall avulsion following incomplete closure with perclose ProStyle: A rare complication
Nagatsuki Tomura, et al. · Journal of Vascular Surgery Cases and Innovative Techniques · 2024
Percutaneous Endovascular Aneurysm Repair Complicated by Shallow Femoral Artery Access
Fumiya Haba, et al. · Cureus · 2025
Comparison of MANTA versus Perclose Prostyle large‐bore vascular closure devices during transcatheter aortic valve implantation
Israel M. Barbash, et al. · Catheterization and Cardiovascular Interventions · 2023
Vascular Closure Device Following Pulsed Field Ablation for Atrial Fibrillation: A Randomized Controlled Trial
A. Dashwood, et al. · Pacing and Clinical Electrophysiology · 2025
Safety and effectiveness of single ProStyle™/ProGlide™ for aortic endovascular procedures: single-style study
Rocco Cangiano, et al. · Frontiers in Cardiovascular Medicine · 2025
Citations indexed from PubMed.
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