PERCLOSE Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Oct 2009
Total Reports
10,164
Reports (30d)
39
Active Signals
0
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
48
reports
Foot Failure During Pre-Close
pre close, pre placed, close technique, prostyle, prostyle device
18
reports
Suture Stuck During Pre-Close
pre close, using pre, pre placed, prostyle, prostyle device
13
reports
Device Stuck in Access Site
closure right, pre placed, close technique, prostyle, prostyle device
10
reports
Sealant Failure During Deployment
control vascular, mynx control, balloon, verified, sealant
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
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
Shintaro Takago, et al. · Annals of Vascular Surgery · 2025
A novel technique for postclosure of large‐bore sheaths using two Perclose devices
Charles H. Choi, et al. · Catheterization and Cardiovascular Interventions · 2020
Propensity‐matched comparison of large‐bore access closure in transcatheter aortic valve replacement using MANTA versus Perclose: A real‐world experience
Giorgio A. Medranda, et al. · Catheterization and Cardiovascular Interventions · 2021
The Side‐Arm Technique on Perclose (STOP) Hemostasis Method to Prevent Bleeding With Indwelling Large Bore Catheters; Concept and Early Results
Stéphane Rinfret, et al. · Catheterization and Cardiovascular Interventions · 2026
Citations indexed from PubMed.
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