OptiCross™ H749518130Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191506035396), received between May 6, 2025 and Sep 4, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Leak/Splash; Air/Gas in Device

  It was reported that catheter issue occurred.An OptiCross imaging catheter was selected for the ultrasound examination of the target lesion. During preparation, the technician noticed that the flushing tubing was leaking, which prevented proper air removal. The procedure was completed with another of same device. The patient remained stable after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614139 ↗
• MalfunctionJan 12, 2026Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION. DURING PREPARATION, THE IVUS CATHETER WAS UNABLE TO BE FLUSHED AND AIR WAS OBSERVED. THE PRODUCT WAS NOT USED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048074 ↗
• MalfunctionOct 22, 2025Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 3OCT2025. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING AN IMAGE RUN, THERE WAS A SNAP SOUND FOLLOWED BY LOSS OF THE IMAGE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE CATHETER WAS TWISTED AND PERFORATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356275 ↗
• MalfunctionJun 24, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND CALCIFIED OBTUSE MARGINAL (OM) ARTERY. ATHERECTOMY WAS PERFORMED WITH A 1.5MM BURR. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION OVER A NON-BOSTON SCIENTIFIC (NON-BSC) WIRE. IVUS SHOWED THAT THE CALCIUM HAD BEEN SUFFICIENTLY MODIFIED, AND AFTER A SUCCESSFUL PULLBACK, THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER OVER THE WIRE. HOWEVER, THE CATHETER COULD NOT BE WITHDRAWN, AND THE WIRE COULD NOT BE ADVANCED FURTHER DOWN THE VESSEL. IT APPEARED THAT THE CATHETER HAD COMPLETELY GRABBED ONTO THE WIRE AND WRAPPED AROUND IT. EVERYTHING HAD TO BE REMOVED AS ONE UNIT. THE VESSEL WAS SUCCESSFULLY REWIRED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320749 ↗
• MalfunctionMay 6, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER WRAPPED ITSELF AROUND THE GUIDEWIRE. THE CATHETER AND GUIDEWIRE WERE REPORTED TOGETHER AND THE PROCEDURE COMPLETED USING ANOTHER OPTICROSS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969080 ↗