ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Aug 2022
Total Reports
19,336
Reports (30d)
89
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Suture Release Failure During Closure
reported clinically, delay procedure, prostyle, prostyle device, femoral vein
50
reports
Suture Break During Arteriotomy Closure
arteriotomy closure, provided arteriotomy, sheath reportedly, prostyle, prostyle device
46
reports
Foot Closure Failure with Device Removal
perclose, prostyle devices, sutures, prostyle, foot
40
reports
Sutures Separated During Knot Advancement
pre close, using pre, pre placed, close technique, prostyle
23
reports
Sutures Failed to Capture Vessel
pre close, sutures, close technique, prostyle, femoral vein
17
reports
Device Link Abnormality During Pre-Close
pre close, arteriotomy closure, pre placed, close technique, prostyle
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
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.
Haba F, et al. · 2025
Infected Pseudoaneurysm Associated With Umbilical Depression at the Puncture Site Due to Perclose ProStyle Suture®: Restoration for Infection Prevention
Daisuke Yamazaki, 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
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.
Keep exploring
Perclose ProGlide
ABBOTT VASCULAR INC. · 24,504 reports
PERCLOSE
ABBOTT VASCULAR INC. · 9,890 reports
Angio-Seal
TERUMO MEDICAL CORPORATION · 6,417 reports
SYNERGY
BOSTON SCIENTIFIC CORPORATION · 5,991 reports
Resolute Onyx
MEDTRONIC, INC. · 4,467 reports
Promus PREMIER
BOSTON SCIENTIFIC CORPORATION · 2,717 reports
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.
Get Early AccessUnderstanding this data
