OptiCross™ 6 H7495181360Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506035433), received between Oct 30, 2025 and Dec 1, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Entrapment of Device; Nonstandard Device; Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, IMAGING WAS TURNED ON, AND THE CATHETER WAS ADVANCED SLIGHTLY. SUDDENLY, THE CATHETER BECAME TANGLED AROUND ITSELF. THE CATHETER AND WIRE GOT STUCK, SO THE PHYSICIAN REMOVED THEM. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682544 ↗
• MalfunctionNov 12, 2025Entrapment of Device; Material Deformation; Physical Resistance/Sticking; Entrapment of Device; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED AND THE VESSEL WAS OCCLUDED. THE 90% STENOSED TARGET LESION AS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. FOLLOWING STENTING, THE OPTICROSS WAS ADVANCED AGAIN, BUT WAS DIFFICULT TO REMOVE AND VESSEL OCCLUSION WAS NOTED. THE OPTICROSS AND GUIDEWIRE WERE REMOVED TOGETHER, AND THE WIRE BROKE IN THE MID-SECTION. THE VESSEL WAS BALLOONED AND THE PROCEDURE CONTINUED AND THE LAD WAS SUCCESSFULLY OPENED. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533475 ↗
• MalfunctionOct 30, 2025Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS 6 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WRAPPED AROUND THE WIRE AND BOTH HAD TO BE REMOVED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424680 ↗