BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Jan 2022
Total Reports
209
Reports (30d)
0
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Air Presence During Flushing
air, patient complications, selected ultrasound, flushing, preparation
1
reports
Catheter Kinked Near Monorail
lesion located, ultrasound ivus, located, moderately, ivus catheter
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Mar 5, 2024 · Open, Classified
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Keep exploring
Perclose ProGlide
ABBOTT VASCULAR INC. · 24,504 reports
Perclose ProStyle
ABBOTT VASCULAR INC. · 19,336 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
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
