OptiCross HD Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Jan 2022 · 3 device variants grouped
Total Reports
733
Reports (30d)
2
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Imaging Catheter Tip Blockage
opticross imaging, examination target, issue occurred, imaging catheter, opticross
47
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
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
Related devices in Coronary
Perclose ProGlide
ABBOTT VASCULAR INC. · 24,665 reports
Perclose ProStyle
ABBOTT VASCULAR INC. · 19,648 reports
PERCLOSE
ABBOTT VASCULAR INC. · 10,164 reports
SYNERGY
BOSTON SCIENTIFIC CORPORATION · 7,061 reports
Angio-Seal
TERUMO MEDICAL CORPORATION · 6,783 reports
Resolute Onyx
MEDTRONIC, INC. · 4,510 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data