OptiCross 18 H7493932700180Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729904748), received between Sep 3, 2019 and Feb 3, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Connection Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED WITH MAY-THURNER SYNDROME COMPLICATED BY A TOTAL THROMBUS IN THE LEFT ILIAC VEIN FOR A PERIPHERAL INTRAVASCULAR ULTRASOUND (IVUS). FOLLOWING BALLOONING WITH A 2.00 X 150 MM STERLING BALLOON, AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR IVUS. WHEN THE CATHETER WAS INSERTED, IT WAS NOT READ BY THE IVUS MACHINE AND WHEN REMOVED, THE TIP OF THE CATHETER WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NOT PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248793 ↗
• InjuryJan 7, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP DETACHED. AN OPTICROSS 18 WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING REMOVAL OF THE CATHETER, THE TIP TORE OFF. THE PHYSICIAN NEEDED TO PERFORM SURGERY IN ORDER TO REMOVE THE TIP. THE DETACHED PORTION OF THE CATHETER WAS ABLE TO BE SUCCESSFULLY REMOVED, AND THE PATIENT WAS ABLE TO FULLY RECOVER.

  Patient problems: Insufficient Information

  MAUDE report 23995172 ↗
• MalfunctionDec 23, 2025Nonstandard Device; Connection Problem; Material Deformation; Nonstandard Device; Connection Problem; Material Deformation

  REASSESSED AS REPORTABLE BASED UPON DEVICE ANALYSIS COMPLETED 10DEC2025. IT WAS REPORTED THAT THE CATHETER WAS NOT RECOGNIZED AND TIP WAS DAMAGED. AN OPTICROSS 18 WAS SELECTED FOR USE. THE DEVICE WAS REPORTED BROKEN AS THE SYSTEM WAS UNABLE TO READ THE CATHETER DATA AND THE TIP WAS NOT LINEAR. THE PROCEDURE WAS COMPLETED WITH AN EQUIVALENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, ANALYSIS REVEALED RIPPLES IN THE IMAGING WINDOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878468 ↗
• MalfunctionMar 28, 2025Poor Quality Image; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FIRST INTRAVASCULAR ULTRASOUND (IVUS) WAS RECORDED. HOWEVER, WHEN USER PULLBACK AND RECORD SECOND RUN, IT WAS NOTED THAT THERE WAS NO IVUS IMAGE SHOWN FROM THE SYSTEM DURING THE SECOND RUN, AND THE PROXIMAL SHAFT FROM THE CATHETER WAS OVER-TWISTED. THE DEVICE WAS REMOVED, 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 21721764 ↗
• MalfunctionNov 20, 2024Poor Quality Image; Poor Quality Image

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT NO IMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). DURING THE PROCEDURE, IT WAS NOTED THAT THE SCREEN HAS NO OUTPUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS GOOD POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT TWIST WAS OBSERVED IN THE IMAGING WINDOW ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738145 ↗
• MalfunctionNov 19, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28OCT2024. IT WAS REPORTED THAT DEVICE KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND HEAVY CALCIFIED VESSEL. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE GOT KINKED WHILE FOLLOWING THE GUIDEWIRE INTO THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A TWIST IN THE IMAGING WINDOW ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724973 ↗
• InjuryOct 17, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER BROKE INSIDE THE PATIENT, REQUIRING ADDITIONAL DEVICES FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR PERIPHERAL PROCEDURE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER DRIVE SHAFT BECAME TWISTED AND THEN SNAPPED, LEAVING A PART OF THE CATHETER INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN DEVICE USING DIFFERENT TECHNIQUES, INCLUDING ALLIGATOR CLIPS AND A SNARE, BUT WAS UNSUCCESSFUL. ON (B)(6) 2024, THE SMALL PIECE OF DEVICE THAT BROKE OFF WAS REMOVED FROM PATIENT'S BODY. THE PATIENT IS GOOD POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED THROUGH MINIMAL INVASIVE TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474557 ↗
• MalfunctionAug 9, 2024Entrapment of Device; Poor Quality Image; Material Twisted/Bent; Entrapment of Device; Poor Quality Image; Material Twisted/Bent

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 18 PERIPHERAL IMAGING CATHETER WAS SELECTED FOR USE. THE CATHETER WAS PLACED OVER A .018 GUIDEWIRE AND ADVANCED SUCCESSFULLY TO THE TARGET LESION AREA. IMAGING WAS TURNED ON BUT ONLY A DARK IMAGE APPEARED. THE CATHETER WAS FLUSHED BUT THAT DID NOT IMPROVE THE IMAGE. AFTER CHECKING THE ELECTRICAL CONNECTION BETWEEN THE CATHETER AND CONSOLE, IT WAS DECIDED TO REMOVE THE CATHETER. AT THIS POINT IT WAS OBSERVED THAT THE GUIDEWIRE WAS ENTANGLED AROUND THE CATHETER. THE CATHETER WAS ULTIMATELY ABLE TO BE REMOVED WITHOUT LOSING RECANALIZATION. A NEW DEVICE, SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949043 ↗
• MalfunctionAug 6, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE DEVICE BECAME ENTANGLED WITH THE GUIDEWIRE. IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) THAT THE REFERENCED OPTICROSS 18 PERIPHERAL IMAGING CATHETER WAS SELECTED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE ON 11JULY 2024. THE LESION WAS LOCATED IN THE LEFT SUPERFICIAL ARTERY TO POPLITEAL ARTERY. DURING THE PROCEDURE, THE OPTICROSS 18 PERIPHERAL IMAGING CATHETER WAS ADVANCED OVER A 0.018 INCH GUIDEWIRE TO THE TIBIOPERONEAL TRUNK. HOWEVER, WHEN ATTEMPTING A PULLBACK, THE IMAGES WERE UNSTABLE AND SHOWED EXCESSIVE DISTORTION ARTIFACTS, AND, THE CATHETER BECAME ENTANGLED WITH THE GUIDEWIRE DURING WITHDRAWAL ATTEMPTS. UPON REMOVAL OF THE OPTICROSS 18 CATHETER FROM THE PATIENT, THE CATHETER WAS OBSERVED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921917 ↗
• MalfunctionJul 16, 2024Entrapment of Device; Poor Quality Image; Entrapment of Device; Poor Quality Image

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED WITH A 50% TORTUOSITY AND 80% CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. WHEN LIVE IMAGING WAS TURNED ON WHILE OUTSIDE THE PATIENT`S BODY, THE STRONG VIBRATION BETWEEN THE WIRE AND THE TRANSDUCER HAD CAUSED THE WIRE TO TANGLE AROUND THE CATHETER AND THE IMAGE ON THE ILAB CONSOLE WAS BLACK. THEY STOP THE LIVE IMAGING IMMEDIATELY. THEY REMOVED THE CATHETER AND RE FLUSHED BUT THE IMAGE WAS STILL BLACK. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751156 ↗
• MalfunctionApr 12, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OCCLUDED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL. THE OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER SPUN AND WAS KINKED. THE CATHETER WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097967 ↗
• MalfunctionMar 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. AN OPTICROSS PERIPHERAL IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTED THAT THE CATHETER UNWOUND ITSELF AROUND THE WIRE. THE CATHETER WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852784 ↗
• MalfunctionFeb 27, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED WITH TIBIAL DISEASE. AN OPTICROSS PERIPHERAL IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE WIRE WRAPPED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790004 ↗
• MalfunctionJan 8, 2024Poor Quality Image; Material Twisted/Bent; Poor Quality Image; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER A V-18 CONTROL WIRE WAS INSERTED, AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE WHILE BEING IN THE LESION, THE CATHETER WAS TURNED ON AND WAS ABLE TO PROVIDE A GOOD IMAGE. HOWEVER, UPON PULLBACK, THE CATHETER TWISTED ON THE WIRE AND THEN THE IMAGE WAS LOST. THE DEVICES HAD TO BE REMOVED TOGETHER AS THEY WERE INTERTWINED. A V-14 GUIDEWIRE AND ANOTHER OPTICROSS 18 CATHETER WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472195 ↗
• MalfunctionDec 1, 2023Poor Quality Image; Material Deformation; Material Twisted/Bent; Poor Quality Image; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 70% STENOSED TARGET LESION IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED COMMON FEMORAL ARTERY. AN OPTICROSS 18 WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE OPTICROSS 18 WAS KINKED AND TWISTED AND DID NOT DISPLAY AN IMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246573 ↗
• MalfunctionJan 21, 2021Detachment 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 SHEATH DETACHMENT OCCURRED. WHEN AN OPTICROSS 18 IMAGING CATHETER WAS BEING REMOVED FROM THE HOOP, IT WAS NOTED THAT THE DEVICE WAS TAKEN APART NEAR THE SHEATH. THE DEVICE DID NOT ENTER THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11210421 ↗
• MalfunctionSep 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. AN OPTICROSS 18 WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE TIP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8957477 ↗