OptiCross™ HD H74939352030Recalls & reported problems

Summary

The FDA's MAUDE database contains 436 adverse event reports that list this exact device (DI 08714729960768), received between Jan 8, 2019 and Sep 30, 2026 — classified as 1 death, 18 injuries, 417 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (159 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 436 reports, 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 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 ↗
• MalfunctionSep 3, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600020 ↗
• MalfunctionAug 3, 2026Entrapment of Device; Failure to Advance

  It was reported that the device became stuck and required intervention. The OptiCross HD imaging catheter was selected for ultrasound examination of the target lesion. During procedure, the physician used an intravascular ultrasound diagnostic catheter, which became stuck inside the vessel and could not advance. Everything was pulled and removed from patient. The procedure experienced a delay of 5 to 10 minutes and completed using a different device. The patient condition following the procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50116341 ↗
• MalfunctionApr 6, 2026No Display/Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; HOWEVER, IMAGING COULD NOT BE INTERPRETED DUE TO A BLACKOUT IMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CATHETER WAS TWISTED, AND THE IMAGING WINDOW WAS RIPPLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790989 ↗
• MalfunctionMar 30, 2026Nonstandard Device; Deformation Due to Compressive Stress

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05 MAR 2026. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE MODERATELY STENOSED TARGET LESION, WITH A LENGTH OF 17 MM, WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND IVUS EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER KINKED AND COULD NOT BE INSERTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT REMAINED STABLE, AND NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CATHETER WAS TWISTED AND THAT THE IMAGING WINDOW WAS RIPPLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716456 ↗
• MalfunctionMar 19, 2026No Display/Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26FEB2026. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION BUT COULD NOT SHOW THE IMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CATHETER WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641360 ↗
• MalfunctionFeb 25, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10FEB2026. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION BUT WAS NOT ABLE TO CROSS THE LESION DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE CATHETER WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442435 ↗
• MalfunctionFeb 24, 2026No Display/Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02 FEBRUARY 2026. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; BUT THE IMAGE COULD NOT BE DISPLAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CATHETER WAS TWISTED AND ENTANGLED WITH THE GUIDEWIRE, AND THE IMAGING WINDOW WAS RIPPLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430557 ↗
• MalfunctionFeb 24, 2026Difficult to Flush

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER COULD NOT BE FLUSHED. AS A RESULT, THE PROCEDURE COULD NOT BE COMPLETED. THE PATIENT REMAINED STABLE, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430546 ↗
• MalfunctionFeb 19, 2026Poor Quality Image; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 95% STENOSED, 32 X 3.0MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). AN OPTICROSS HD CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION (IVUS) OF THE TARGET LESION. DURING INITIAL TESTING OUTSIDE THE PATIENT, THE CATHETER HAD BUBBLES WHICH LED TO POOR IMAGE QUALITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395381 ↗
• MalfunctionFeb 19, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AFTER PRIMING THE CATHETER, IMAGING WAS INITIATED AND SALINE WAS PUSHED IN. A FOREIGN BODY WAS FOUND AT THE TIP OF THE CATHETER, SO THE ORIGINAL CATHETER WAS NOT USED. A NEW IVUS TUBE WAS USED FOR THE PROCEDURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391890 ↗
• MalfunctionFeb 18, 2026Difficult to Flush

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. THE TARGET LESION WAS LOCATED IN THE ANTERIOR DESCENDING BRANCH ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING INTRODUCTION, THE DEVICE COULD NOT BE FLUSHED. AS A RESULT, THE PROCEDURE WAS NOT COMPLETED. THE PATIENT REMAINED STABLE, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381391 ↗