OptiCross 18 H7493932800180Recalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 08714729904366), received between Sep 4, 2018 and Jan 27, 2026 — classified as 30 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (64 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. THE OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, SPECIFICALLY DURING PULLBACK AS IMAGING BEGAN, THE IVUS CATHETER KINKED AT THE MIDSHAFT AND WRAPPED AROUND A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE PHYSICIAN REMOVED BOTH THE IVUS CATHETER AND THE WIRE FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT FULLY RECOVERED, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192298 ↗
• MalfunctionNov 12, 2025Failure to Advance; Deformation Due to Compressive Stress; Material Twisted/Bent; Failure to Advance; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED TARGET LESION. THE OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THERE WAS NO DIFFICULTY ADVANCING TO POSITION, BUT THERE WAS DIFFICULTY ADVANCING IN THE POPLITEAL. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED TO BE BENT AND TWISTED. THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED WITH NO FURTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531709 ↗
• MalfunctionOct 15, 2025Poor Quality Image; Material Twisted/Bent; Poor Quality Image; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% OR MORE STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS, SEVERELY CALCIFIED TIBIAL ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED OVER A V18 CONTROL WIRE. NO IMAGE APPEARED WHEN IMAGING WAS TURNED ON DURING PULLBACK AND IT WAS NOTED THAT THE CATHETER WAS WRAPPED ON ITSELF. THE DEVICE WAS REMOVED AND EVALUATED AT WHICH TIME SPIRAL COILING OF THE TIP OF THE CATHETER WAS NOTICED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280442 ↗
• MalfunctionSep 16, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS PERIPHERAL IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PROCEDURE, AN UNKNOWN GUIDEWIRE PIERCED AND EXITED THE CATHETER APPROXIMATELY HALFWAY THROUGH THE LOADING PROCESS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069595 ↗
• MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MESENTERIC ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE FRACTURED IN THE CELIAC ARTERY VIA THE FEMORAL APPROACH. ALL COMPONENTS REMAINED ON THE WIRE AND WERE SAFELY RETRIEVED FROM THE ARTERY AS A SINGLE UNIT. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067634 ↗
• MalfunctionJul 3, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WRAPPED AROUND WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE AND NEEDED TO BE REMOVED ENTIRELY. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399162 ↗
• MalfunctionJul 3, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  A CATHETER ISSUE WAS REPORTED DURING THE PROCEDURE. THE 90% STENOSED TARGET LESION WAS LOCATED IN A LIMITED TORTUOUS, AND MILDLY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA). AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER DEPLOYED TO POSITION BUT WRAPPED AROUND A NON-BOSTON SCIENTIFIC (NON-BSC) WIRE DURING RECORDING PULLBACK. THE CATHETER WAS THEN PULLED OUT ALONG WITH THE NON-BSC WIRE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393939 ↗
• MalfunctionMay 14, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. UPON CROSSING THE LESION, IT WAS NOTED THAT THE CATHETER TIP BROKE. THE DEVICE WAS REMOVED IN ONCE PIECE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018099 ↗
• InjuryApr 9, 2025Detachment of Device or Device Component; Material Integrity Problem; Material Twisted/Bent; Detachment of Device or Device Component; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER BECAME TANGLED AND SEPARATED, REQUIRING INTERVENTION. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS USED FOR A PERIPHERAL INTERVENTION PROCEDURE FOR ARTERIAL DISEASE. DURING THE PROCEDURE, THE CATHETER TWISTED AROUND ITSELF IN THE BODY AND THEN SEPARATED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21808008 ↗
• MalfunctionMar 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. AN OPTICROSS 18 WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THERE WAS A HAIR (FOREIGN MATTER) WITHIN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718960 ↗
• MalfunctionMar 20, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER GOT STUCK WITH THE GUIDEWIRE. AN OPTICROSS 18 CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO USE THE DEVICE WITH A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE. HOWEVER, IT WAS NOTED THAT THE CATHETER GOT STUCK ON THE WIRE, SO THEY HAD TO REMOVE BOTH THE WIRE AND DEVICE TOGETHER AND LOST WIRE ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657896 ↗
• MalfunctionFeb 20, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE ENTANGLEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN OPTICROSS 18 WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC 018 GUIDEWIRE, AND IMAGES WERE TAKEN IN THE SFA AND INSIDE THE STENT IN THE SFA. WHILE IMAGING, THE CATHETER BECAME WRAPPED AROUND THE GUIDEWIRE DURING ADVANCEMENT. AS A RESULT, THE GUIDEWIRE AND IVUS CATHETER HAD TO BE WITHDRAWN DUE TO ENTANGLEMENT. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER NON-BOSTON SCIENTIFIC GUIDEWIRE AND ANOTHER OF THE SAME OPTICROSS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424978 ↗
• MalfunctionFeb 12, 2025Poor Quality Image; Poor Quality Image

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JAN2025. IT WAS REPORTED CATHETER ISSUE OCCURRED. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE IMAGE WAS VERY DARK AND LOOKED TERRIBLE. THE CATHETER WAS REPLACED WITH A DIFFERENT DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED TWIST IN THE IMAGING WINDOW ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370011 ↗
• InjuryFeb 4, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP MARKERBAND DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING REMOVAL OF THE CATHETER, IT WAS NOTED THAT THE TIP OF THE CATHETER WITH THE RADIOPAQUE PORTION WAS DETACHED AND STILL IN THE PATIENT. THE DETACHED PORTION WAS REMOVED WITH A SNARE AND THE ENTIRE DETACHED PORTION WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305330 ↗
• MalfunctionFeb 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT FIBER BREAK OCCURRED. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS USED FOR PERIPHERAL ANGIOGRAM. HOWEVER, THE FIBER BROKE DURING THE PROCEDURE. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304729 ↗
• MalfunctionFeb 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER SEPARATION OCCURRED. A OPTICROSS 18 VASCULAR IMAGING CATHETER WAS USED DURING THE PROCEDURE. UPON WITHDRAWAL, THE CATHETER GOT SEPARATED FROM THE WIRE EITHER INSIDE THE BODY OR WHILE BEING REMOVED FROM SHEATH. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294058 ↗
• MalfunctionDec 18, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTANGLEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS SELECTED FOR USE. DURING DEVICE PULLBACK, IT WAS REPORTED THAT THE UNKNOWN GUIDEWIRE BECAME WRAPPED AROUND THE OPTICROSS CATHETER MID-SHAFT, RENDERING THE CATHETER NON-FUNCTIONAL. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE IVUS CATHETER TWISTED ON ITSELF AND TRAPPING THE NON-BOSTON SCIENTIFIC WIRE WITHIN IT. THE CATHETER AND THE WIRE WERE REMOVED FROM PATIENT AS ONE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20968348 ↗
• MalfunctionDec 16, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE MORE THAT 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 WAS ADVANCED OVER A 018 THRUWAY GUIDEWIRE. HOWEVER, THE WIRE SEEMED TO EXIT THE MONORAIL PORTION PREMATURELY. IT SEEMED THAT THE DEVICE HAD SEPARATED FROM THE MAIN PORTION OF THE DELIVERY SHAFT. THERE WAS NO ISSUE NOTED WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTICROSS 18 AND THE SAME THRUWAY GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20947452 ↗
• InjuryDec 5, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND TIP DETACHMENT OCCURRED, REQUIRING SNARE FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR LOWER EXTREMITY ANGIOGRAM. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER SPUN AROUND THE WIRE AND BROKE OFF INSIDE THE PATIENT'S BODY. THE BROKEN TIP WAS RECOVERED USING A NON-BOSTON SCIENTIFIC (BSC) SNARE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857590 ↗
• MalfunctionDec 4, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE WIRE WRAPPED WITH THE CATHETER. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS SELECTED FOR PERIPHERAL ARTERIAL DISEASE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED THE .014 THRUWAY GUIDEWIRE WRAPPED WITH THE CATHETER, IT WAS STUCK AND WAS UNABLE TO COMPLETE THE PULLBACK. BOTH THE CATHETER AND WIRE WERE REMOVED AS ONE UNIT. AND IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTICROSS 18 DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846829 ↗
• MalfunctionNov 18, 2024Entrapment of Device; Poor Quality Image; Device Displays Incorrect Message; Entrapment of Device; Poor Quality Image; Device Displays Incorrect Message

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE COULD NOT PROVIDE IMAGING BEYOND A GRAINY BACKGROUND SCREEN FROM THE BEGINNING. SUBSEQUENTLY, THE DEVICE EXPERIENCED A POWER OVERLOAD, CAUSING THE CATHETER TO WRAP AROUND THE GUIDEWIRE WHEN THE IMAGING WAS STOPPED. AN ATTEMPT TO UNPLUG AND RECONNECT TO THE MOTOR DRIVE UNIT (MDU) WAS PERFORMED, BUT THE ISSUE PERSISTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER OPTICROSS 18. MOREOVER, THE PATIENT WAS DOING WELL POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711840 ↗
• MalfunctionNov 12, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE ENTANGLEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, WHILE RUNNING IVUS, THE DEVICE WRAPPED AROUND THE WIRE. THE WIRE AND THE CATHETER WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW WIRE AND IVUS CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665036 ↗
• MalfunctionNov 7, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTANGLEMENT OCCURRED. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED MID TO DISTAL SUPERFICIAL FEMORAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE OPTICROSS WRAPPED AROUND THE NON-BOSTON SCIENTIFIC WIRE. THE WIRE AND CATHETER WERE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626381 ↗
• MalfunctionNov 7, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ANGIOGRAM. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE CATHETER SPUN ON THE WIRE AND TWISTED BEFORE ENTERING THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626277 ↗
• MalfunctionNov 6, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE WIRE TWISTED ON THE CATHETER. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS SELECTED FOR USE. HOWEVER, THE NON-BOSTON SCIENTIFIC GUIDEWIRE TWISTED ON THE CATHETER DURING THE PROCEDURE. BOTH DEVICES WERE REMOVED AS ONE UNIT, AND THE PROCEDURE WAS COMPLETED WITH A NEW WIRE AND CATHETER. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625334 ↗