ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Oct 2009
Total Reports
24,504
Reports (30d)
56
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Suture Break During Arteriotomy Closure
proglide device, arteriotomy closure, provided arteriotomy, proglide, sheath reportedly
68
reports
Literature Batch: TAVR Vascular Complications
valve, aortic, complications, proglide, prostyle
26
reports
Suture Release Failure During Closure
reported clinically, delay procedure, prostyle, prostyle device, femoral vein
17
reports
Device Link Abnormality During Pre-Close
pre close, arteriotomy closure, pre placed, close technique, prostyle
14
reports
Sutures Separated During Knot Advancement
pre close, using pre, pre placed, close technique, prostyle
11
reports
Foot Closure Failure with Device Removal
perclose, prostyle devices, sutures, prostyle, foot
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter Aortic Valve Implantation
Beytullah Çakal, et al. · Texas Heart Institute Journal · 2022
Watchman Device Procedure Complicated by Rare Perclose ProGlide Embolization: Case Report and Literature Review
Rafail Beshai · Cureus · 2022
Efficacy and safety of post-closure technique using Perclose ProGlide/ProStyle device for large-bore mechanical circulatory support access sites
Takashi Unoki, et al. · Cardiovascular revascularization medicine · 2023
Ambulatory pulmonary vein isolation workflow using the Perclose ProglideTM suture-mediated vascular closure device: the PRO-PVI study
Davide Fabbricatore, et al. · EP Europace · 2023
Femoral vessel cannulation strategies in minimally invasive cardiac surgery: single Perclose ProGlide versus open cut-down
Majd Ismail, et al. · European Journal of Cardio-Thoracic Surgery · 2025
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. 2 active signals detected right now.
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