OptiCross™ HD H74939352040Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 08714729960737), received between Dec 6, 2018 and Feb 17, 2026 — classified as 3 deaths, 34 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (42 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 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27 JANUARY 2026. THE OPTICROSS HD IMAGING CATHETER WAS RETURNED WITHOUT ANY ALLEGATION OF A DEVICE ISSUE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DISTAL SECTION OF THE TIP WAS DAMAGED AND PARTIALLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370053 ↗
• MalfunctionJan 5, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE TIP BROKE OFF IN THE PATIENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970027 ↗
• MalfunctionDec 11, 2025No Display/Image; Nonstandard Device; Detachment of Device or Device Component; No Display/Image; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION FOR THE TARGET LESION. DURING THE PROCEDURE, IMAGING STARTED AND STOPPED ON ITS OWN. UPON REMOVAL, THE CATHETER TIP WAS FOUND BROKEN. THE DEVICE WAS REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776983 ↗
• MalfunctionSep 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PREPARATION, A HAIR WAS FOUND INSIDE THE STERILE PACKAGING. THE DEVICE WAS DISCARDED AND THE PROCEDURE COMPLETED WITH ANOTHER OF DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936105 ↗
• MalfunctionAug 12, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN AN ABORTED PROCEDURE. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING THE PREPARATION, THE CATHETER COULD NOT SHOW THE IMAGE, HOWEVER THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790451 ↗
• MalfunctionJul 22, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE CATHETER BECAME TANGLED WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569131 ↗
• InjuryJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE POST STENT PLACEMENT IVUS RUN, THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. COMPUTER TOMOGRAPHY (CT) WAS PERFORMED BUT THE CATHETER TIP WAS NOT SHOWN. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22420719 ↗
• MalfunctionJul 1, 2025Entrapment of Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER GOT STUCK ON THE WIRE, TWISTED AND BROKE THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376528 ↗
• DeathMay 22, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT MAIN CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) OF THE TARGET LESION. AS THE PHYSICIAN ATTEMPTED TO PASS THE IVUS CATHETER ACROSS THE LESION, IMAGING WAS ACTIVATED AND AN ARTIFACT WAS OBSERVED ON THE SCREEN. THE TECHNICIAN WAS ASKED WHETHER FLUSHING WAS OCCURRING, AND THEY CONFIRMED THAT IT WAS. THE TECHNICIAN WAS THEN INSTRUCTED TO STOP FLUSHING, AND THE PHYSICIAN AND TECHNICIAN DECIDED TO REMOVE AND RE-PREP THE CATHETER. THE PHYSICIAN NOTED ELEVATED ST-SEGMENTS, AND CONTRAST INJECTION REVEALED A SLOW-FLOW PHENOMENON. A DECISION WAS MADE TO ASPIRATE THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ASPIRATION WAS PERFORMED, WHICH RESTORED SOME FLOW TO THE PROXIMAL LAD. HOWEVER, THE PATIENTS CONDITION WORSENED, AND THEY WENT INTO CARDIAC ARREST WITH PULSELESS ELECTRICAL ACTIVITY (PEA). CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND A PERCUTANEOUS LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS INSERTED. CORONARY ANGIOGRAPHY PERFORMED AFTER IMPELLA PLACEMENT SHOWED NORMAL CORONARY FLOW. DESPITE EFFORTS, THE PATIENT DIED FOLLOWIN

  Patient problems: Air Embolism; Cardiac Arrest; Non specific EKG/ECG Changes; Reduced Blood Flow

  MAUDE report 22074303 ↗
• MalfunctionMay 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHEATH DETACHMENT OCCURRED. DURING A POST-PCI IVUS RUN, IT WAS DETERMINED THAT THE OPTICROSS HD HAD SEPARATED INTERNALLY, THE OUTER SLEEVE REMAINED IN THE VESSEL WHILE THE INNER SLEEVE WAS NEAR THE CATHETER-SLED CONNECTION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH NO REPORTED ADVERSE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057375 ↗
• MalfunctionApr 3, 2025Poor Quality Image; Material Deformation; Material Integrity Problem; Poor Quality Image; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. WHEN THE IVUS CATHETER WAS TESTED PRIOR TO INSERTION, THE IMAGE DISPLAYED NON-UNIFORM ROTATIONAL DISTORTION (NURD), AND A KINK WAS FOUND IN THE CATHETER. IT WAS FURTHER NOTED THAT THE CATHETER WAS FRACTURED/SEPARATED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766817 ↗
• MalfunctionMar 28, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WAS INSERTED WITHOUT COMPLICATIONS. HOWEVER, UPON REMOVAL, THE MONORAIL PROLAPSED ON THE WIRE. BOTH THE WIRE AND CATHETER WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719302 ↗
• MalfunctionMar 3, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID CIRCUMFLEX ARTERY. A 6F GUIDEZILLA II, AN OPTICROSS HD AND A MARVEL GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT UPON CROSSING THE PROXIMAL LESION, THE PHYSICIAN FELT RESISTANCE, THEN TURNED OFF IMAGING AND HAD TO PULL OUT ALL THREE DEVICES AS A UNIT. FURTHERMORE, THE MARVEL GUIDEWIRE OR GUIDEZILLA COULD NOT SEPARATE FROM THE OPTICROSS. THE PROCEDURE WAS COMPLETED WITH THE USE OF A DIFFERENT NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510677 ↗
• InjuryFeb 11, 2025Off-Label Use; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND CATHETER TWISTED UPON ITSELF. HOWEVER, THE DEVICE WAS SUCCESSFULLY RETRIEVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353186 ↗
• MalfunctionNov 26, 2024Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE HAD TROUBLE CROSSING THE LESION AND APPEARED FRACTURED OR SPLIT UNDER X-RAY. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786530 ↗
• MalfunctionOct 16, 2024Entrapment of Device; Poor Quality Image; Material Integrity Problem; Material Twisted/Bent; Output Problem; Entrapment of Device; Poor Quality Image; Material Integrity Problem; Material Twisted/Bent; Output Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER STARTED SPINNING OUT OF CONTROL AND IMAGING WAS LOST. THE CATHETER ALMOST SEPARATED INTO A KNOT AND COULD NOT BE PULLED BACK. THE CATHETER AND GUIDEWIRE WERE EVENTUALLY REMOVED AS ONE UNIT. THE GUIDEWIRE WAS ABLE TO BE SEPARATED FROM THE CATHETER ONCE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT IVUS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466131 ↗
• InjurySep 23, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT SERIOUS INJURY OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IMAGE WAS DARK THEREFORE THE CATHETER WAS FLUSHED HOWEVER THERE WAS A MICRO BUBBLES PRESENT. DURING THE PULLBACK, THE PATIENT BECAME ISCHEMIC. MEDICATION WAS GIVEN TO THE PATIENT AND THE ISCHEMIA WENT AWAY. THE PATIENT ALSO EXPERIENCED AN AIR EMBOLISM AND ST SEGMENT ELEVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT FULLY RECOVERED.

  Patient problems: Air Embolism; Ischemia; Non specific EKG/ECG Changes

  MAUDE report 20281608 ↗
• MalfunctionAug 12, 2024Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE THE CATHETER UNRAVELED ITSELF AND THE TIP WAS DAMAGE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960679 ↗
• InjuryJul 24, 2024Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS CIRCUMFLEX ARTERY. AN OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER WAS DIFFICULT TO ADVANCE. WHEN IT WAS PULLED BACK TO REMOVE, THE TIP BROKE OFF AND REMAINED IN THE PATIENT. THE GUIDE CATHETER WAS CHECKED, AND ANGIOGRAPHY WAS USED BUT THE TIP COULD NOT BE LOCATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19820780 ↗
• MalfunctionJun 24, 2024

  OPTICROSS IVUS CATHETER LABELED AS A 3FR CORONARY CATHETER CAME UP AS A PERIPHERAL CATHETER WHEN CONNECTED TO THE IVUS CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593455 ↗
• MalfunctionJun 13, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RAMUS ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER BECAME FRACTURED AT THE MONORAIL PORTION AND WAS STUCK. AFTER REMOVING THE DEVICE FROM THE GUIDE CATHETER, IT WAS NOTED THAT THE TIP WAS MISSING. THE PHYSICIAN REMOVED EVERYTHING, 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 19533973 ↗
• InjuryJun 13, 2024Poor Quality Image; Detachment of Device or Device Component; Material Deformation; Poor Quality Image; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PROCEDURE, THE PHYSICIAN WAS CONCERNED THAT THERE WAS A POSSIBLE FRACTURE IN THE MONORAIL PORTION THAT COULD HAVE CAUSED A POSSIBLE AIR EMBOLUS AND PATIENT HAD SOME ST ELEVATION. THE CATHETER WAS REMOVED AND FLUSHED TO ENSURE THE TIP WAS STILL INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT DID VERY WELL.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 19533625 ↗
• MalfunctionMay 29, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; 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 SEVERELY CALCIFIED VESSEL. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WAS FRACTURED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DEVICE BY INTRODUCING A GUIDE EXTENSION, PULLING THE DEVICE INTO THE EXTENSION, AND COMPLETELY REMOVING IT FROM THE PATIENTS 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 19418131 ↗
• MalfunctionMay 24, 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 A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING INSERTION, DIFFICULTY IN TRACKING AND RETRACTING ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE WAS ENCOUNTERED. THE IVUS CATHETER COULD NOT BE REMOVED FROM THE GUIDEWIRE. THE IVUS CATHETER WAS REMOVED ALONG WITH THE GUIDEWIRE THROUGH THE GUIDE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19396281 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS USED TOGETHER WITH THE IVUS CATHETER. DURING PULLBACK, THE WIRE CORE BECAME SEPARATED FROM THE SHAFT. THE PHYSICIAN WAS ABLE TO REMOVE EVERYTHING BY PULLING IT OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378581 ↗