ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Oct 2009
Total Reports
9,890
Reports (30d)
70
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Suture Break During Arteriotomy Closure
arteriotomy closure, provided arteriotomy, sheath reportedly, prostyle, prostyle device
61
reports
Device Link Abnormality During Pre-Close
pre close, arteriotomy closure, pre placed, close technique, prostyle
21
reports
Faulty Device Causing Blood Pooling
reported clinically, delay procedure, prostyle, prostyle device, significant delay
17
reports
Sutures Separated During Knot Advancement
pre close, using pre, pre placed, close technique, prostyle
10
reports
Suture Release Failure During Closure
reported clinically, delay procedure, prostyle, prostyle device, femoral vein
9
reports
Literature Batch: TAVR Vascular Complications
valve, aortic, complications, proglide, prostyle
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Single Versus Double Perclose Vascular Closure Device in Transfemoral Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis
Nikolaos Vythoulkas-Biotis, et al. · Angiology · 2026
Single Versus Double Perclose Devices for TF-TAVR Access Closure
Jubo Jiang, et al. · JACC Asia · 2026
Safety and Effectiveness of the Single Perclose Method with Large-Bore Sheaths.
Takago S, et al. · 2025
Single perclose escalation technique: A novel approach for vascular closure following Transcatheter Aortic Valve Replacement
Andrea Monastyrski, et al. · International Journal of Cardiology · 2025
A novel technique for postclosure of large‐bore sheaths using two Perclose devices
Charles H. Choi, et al. · Catheterization and Cardiovascular Interventions · 2020
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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