OptiCross HDRecalls & reported problems across all models
Boston Scientific Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 592
- Deaths reported
- 4
- Injuries reported
- 63
- Recalls
- 0
We found 3 models of OptiCross HD by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 592 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2018 and Sep 30, 2026 — classified as 4 deaths, 63 injuries, 525 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (186 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OptiCross HD problems
Device problems
- Adverse Event Without Identified Device or Use Problem239
- Poor Quality Image186
- Detachment of Device or Device Component103
- Material Integrity Problem79
- Material Deformation76
- Entrapment of Device68
- Failure to Advance60
- Nonstandard Device51
Patient problems
- No Clinical Signs, Symptoms or Conditions541
- Foreign Body In Patient17
- Air Embolism14
- Non specific EKG/ECG Changes12
- No Consequences Or Impact To Patient9
- Obstruction/Occlusion6
- Chest Pain3
- Reduced Blood Flow3
OptiCross HD models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OptiCross™ HD H74939352030Catheter, ultrasound, intravascular1 death436 reports
- OptiCross™ HD H74939352040Catheter, ultrasound, intravascular3 deaths116 reports
- OptiCross™ HD H74939352050Transducer, ultrasonic, diagnostic40 reports
Recent OptiCross HD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image; Poor Quality Image; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948184 ↗MalfunctionSep 30, 2026Entrapment of Device; Material Deformation
It was reported that a catheter issue occurred.The 86% stenosed target lesion was located in the moderately calcified left anterior descending artery. An OptiCross HD imaging catheter was advanced for intravascular ultrasound (IVUS) examination of the target lesion. During the procedure, the catheter fractured and became entangled. The procedure was completed using another device of the same model. There were no patient complications, and the patient remained stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945817 ↗MalfunctionSep 29, 2026Unable to Obtain Readings; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933345 ↗MalfunctionSep 28, 2026Unable to Obtain Readings; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923695 ↗MalfunctionSep 25, 2026Entrapment of Device; Material Deformation
It was reported that a catheter issue occurred.The 85% stenosed target lesion was located in the mildly calcified and mildly tortuous mid right coronary artery (RCA). The OptiCross HD imaging catheter was selected for intravascular ultrasound (IVUS) examination of the target lesion. The IVUS run was completed without issue. During catheter removal, resistance was encountered and the guidewire was pulled out with the catheter. Upon inspection, the catheter was noted to be torn or broken, and the guidewire exhibited a sharp U bend. The procedure was completed with another of the same device. The patient condition following the procedure was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893175 ↗MalfunctionSep 24, 2026Entrapment of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892208 ↗MalfunctionSep 24, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890739 ↗MalfunctionSep 24, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890387 ↗MalfunctionSep 24, 2026Unable to Obtain Readings; Material Integrity Problem; Air/Gas in Device
It was reported that catheter issue occurred.An OptiCross HD imaging catheter was selected for intravascular ultrasound (IVUS) examination of the target lesion. During preparation, the extension catheter was bulged, it was also noted that the air could not be discharged and the catheter was black during test outside the patient. The procedure was completed with another of same device. The patient was stable following the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885291 ↗MalfunctionSep 24, 2026Material Deformation
It was reported that catheter issue occurred. An OptiCross HD imaging catheter was selected for ultrasound examination of the left anterior descending (LAD) artery. During the procedure, the device got fractured. Another of the same model was used to complete the procedure. No complications were reported, and the patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882181 ↗MalfunctionSep 23, 2026Unable to Obtain Readings; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874656 ↗MalfunctionSep 23, 2026No Display/Image; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874046 ↗MalfunctionSep 23, 2026No Display/Image; Poor Quality Image; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873775 ↗MalfunctionSep 23, 2026Unable to Obtain Readings; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873773 ↗MalfunctionSep 23, 2026Unable to Obtain Readings; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870922 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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