OptiCross™ 6 HD H74939354090Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00191506035457), received between Jul 17, 2024 and Sep 30, 2026 — classified as 10 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (43 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 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Entrapment of Device; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948183 ↗
• MalfunctionSep 30, 2026Failure to Advance; Material Deformation

  It was reported that catheter issue occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending (LAD) artery. The left main artery was not calcified. An OptiCross 6 HD imaging catheter was advanced into the left main artery. Resistance was encountered while advancing toward the LAD, possibly due to the left main angulation and the catheter began to separate from the wire. When the device was removed, it was noted that the catheter had begun to separate. The procedure was completed using another of the same device. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945072 ↗
• MalfunctionSep 24, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890741 ↗
• MalfunctionSep 2, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571744 ↗
• MalfunctionSep 1, 2026Entrapment of Device

  It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery. An OptiCross 6 HD imaging catheter was advanced for intravascular ultrasound (IVUS) examination of the target lesion. During the procedure, the non-Boston Scientific guidewire became wrapped around the distal portion of the catheter at the monorail port. The guidewire and catheter were removed together as a single unit, and the vessel was successfully rewired with a new guidewire without issue. The procedure was completed with another of the same device. There were no patient complications, and the patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550387 ↗
• MalfunctionAug 21, 2026Entrapment of Device

  It was reported that a catheter issue occurred.An OptiCross 6 HD imaging catheter was selected for ultrasound examination of the target lesion. During a percutaneous coronary intervention, the catheter became wrapped around the guidewire. The device was removed. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50370180 ↗
• InjuryAug 6, 2026Detachment of Device or Device Component; Material Deformation

  It was reported that a catheter issue occurred. The patient presented for an ST-elevation myocardial infarction (STEMI) procedure involving two layers of existing stents. The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified mid-right coronary artery. An OptiCross HD imaging catheter was advanced for intravascular ultrasound (IVUS) examination of the target lesion. The catheter would not cross the lesion, and during the use of a second OptiCross catheter, the tip broke off. The detached tip remained within the patient and was secured in place by a stent. The procedure was completed using another of the same device. There were no patient complications, and the patient outcome was stable. However, within days, the patient returned with a STEMI approximately 20 mm proximal to the location of the retained tip. The last information obtained was that the patient was stable.

  Patient problems: Foreign Body In Patient

  MAUDE report 50161139 ↗
• MalfunctionJul 31, 2026Entrapment of Device; Nonstandard Device; Difficult to Remove; Deformation Due to Compressive Stress

  It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery. The OptiCross 6 HD imaging catheter was advanced for intravascular ultrasound (IVUS) examination of the target lesion. During the procedure, the physician prepped the lesion and then readvanced the OptiCross catheter to ensure the lesion was ready to be stented. The OptiCross catheter became stuck on the guidewire and could not be separated. Attempts to push and pull the guidewire and catheter did not resolve the issue. The physician removed both the OptiCross catheter and the guidewire in one piece. The guidewire could not be separated from the catheter after removal from the patient, and both devices were severely damaged and kinked. The procedure was completed with another of the same device. The patient fully recovered, and no patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099646 ↗
• MalfunctionJul 30, 2026Difficult to Flush; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091208 ↗
• MalfunctionJul 29, 2026Nonstandard Device; Material Deformation; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073386 ↗
• MalfunctionMar 18, 2026Unable to Obtain Readings; Connection Problem; Air/Gas in Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION, THE DEVICE SHOWED NO IMAGE AND AIR WAS NOT REMOVED FROM THE CATHETER DURING FLUSHING. THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634190 ↗
• MalfunctionMar 3, 2026Entrapment of Device; Material Deformation

  IT WAS REPORTED VIA MEDSUN (B)(4) THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND CATHETER BECAME STUCK DURING REMOVAL. THE WIRE AND CATHETER WERE PULLED OUT, AND IT APPEARED THAT THE WIRE HAD SPLIT OR THE CATHETER HAD BROKEN. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500185 ↗
• MalfunctionMar 3, 2026Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO NAVIGATE THE CATHETER THROUGH TORTUOUS ANATOMY. WHEN THE IVUS CATHETER WAS TURNED ON TO LIVE IMAGING, THE TRANSDUCER GRABBED THE GUIDEWIRE AND THE DEVICES BECAME ENTANGLED. ALL DEVICES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE COMPLETED WITHOUT USING IVUS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497237 ↗
• MalfunctionFeb 17, 2026No Display/Image; Entrapment of Device; Nonstandard Device; Failure to Advance

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. AN OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, NO IMAGE DISPLAYED, AND THE CATHETER WOULD NOT MOVE ON THE WIRE. THE CATHETER WAS WITHDRAWN ON THE WIRE, AND ONCE IT WAS OUTSIDE THE VESSEL, IT WAS DISCOVERED THAT THE CATHETER HAD UNRAVELED AND BECOME TANGLED AROUND THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366188 ↗
• MalfunctionFeb 17, 2026Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER WAS LOADED ONTO THE GUIDEWIRE, AND THE TRANSDUCER BEGAN SPINNING ON ITS OWN, WITH NO ONE TOUCHING ANY BUTTONS. THE BACK END/SHAFT OF THE CATHETER BECAME MANGLED. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365587 ↗
• MalfunctionFeb 16, 2026Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER WAS DELIVERED WITH LITTLE TO NO RESISTANCE. DURING PULLBACK, WHEN ATTEMPTING TO WITHDRAW THE CATHETER INTO THE GUIDE, THE PHYSICIAN NOTED THAT IT WOULD NOT REENTER THE GUIDE CATHETER. THE ENTIRE SYSTEM, INCLUDING THE GUIDE CATHETER, GUIDEWIRE, AND IVUS CATHETER, WAS REMOVED FROM THE PATIENT. UPON INSPECTION, THE GUIDEWIRE WAS FOUND TO HAVE FOLDED ON ITSELF AND WRAPPED AROUND THE MONORAIL PORTION OF THE CATHETER. THE PHYSICIAN SUBSEQUENTLY REWIRED THE VESSEL WITHOUT ISSUE, STENT PLACEMENT WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT FULLY RECOVERED AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343380 ↗
• MalfunctionFeb 2, 2026Failure to Advance; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR EXAMINATION. DURING THE PROCEDURE, THE DEVICE HAD DIFFICULTY ADVANCING AND RESISTANCE WAS FELT WHEN REMOVING THE CATHETER, SO THE NON-BOSTON SCIENTIFIC (NON-BSC) WIRE WAS ALSO REMOVED. ONCE OUT OF THE BODY, IT WAS NOTICED THAT THE TIP WAS BROKE OFF AT THE DISTAL MARKER BAND AND REMAINED ON THE NON-BSC WIRE, WITH NOTHING LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT PERFORMING IMAGINING, AND THE PATIENT FULLY RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242018 ↗
• MalfunctionJan 27, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED CATHETER ISSUES OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE GUIDEWIRE BECAME ENTANGLED WITH THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THE WIRE AND CATHETER WERE REMOVED AS A UNIT AND THE PROCEDURE COMPLETED USING A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS ALSO INDICATED THAT A SECOND OPTICROSS 6 HD IMAGING CATHETER HAD TIP DAMAGE, DIFFICULTY TRACKING ON THE WIRE, AND BECAME FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193196 ↗
• MalfunctionJan 27, 2026Entrapment of Device

  IT WAS REPORTED CATHETER ISSUES OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE GUIDEWIRE BECAME ENTANGLED WITH THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THE WIRE AND CATHETER WERE REMOVED AS A UNIT AND THE PROCEDURE COMPLETED USING A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS ALSO INDICATED THAT A SECOND OPTICROSS 6 HD IMAGING CATHETER HAD TIP DAMAGE, DIFFICULTY TRACKING ON THE WIRE, AND BECAME FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193166 ↗
• MalfunctionJan 22, 2026Entrapment of Device; Failure to Advance

  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, THE GUIDEWIRE BECAME LODGED WITHIN THE IVUS CATHETERS INNER LUMEN, PREVENTING FURTHER ADVANCEMENT INTO THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146704 ↗
• MalfunctionJan 12, 2026Entrapment of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER WAS KINKED AT THE DISTAL TIP NEAR THE MONORAIL. UPON REMOVAL, THE CATHETER BECAME STUCK ON THE GUIDEWIRE AND COULD NOT BE REMOVED SEPARATELY. A NON-BOSTON SCIENTIFIC GUIDEWIRE REMAINED ATTACHED TO THE DEVICE. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE IVUS CATHETER AND GUIDEWIRE TOGETHER AS ONE PIECE. THE PATIENT FULLY RECOVERED, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048066 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, A PIECE OF THE DISTAL TIP OF THE IVUS CATHETER BROKE OFF INSIDE THE PATIENTS VESSEL. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24047688 ↗
• MalfunctionJan 12, 2026Contamination

  IT WAS REPORTED THAT CONTAMINATION WAS NOTED. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. WHEN THE DEVICE PACKAGING WAS OPENED, CONTAMINATION WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040392 ↗
• InjuryJan 7, 2026Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. AFTER THE LESION WAS CROSSED, IT WAS INDICATED THAT THE DEVICE STUCK AND A PIECE OF THE CATHETER BROKE OFF IN THE DISTAL PORTION OF THE VESSEL. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE USING A SNARE, AND IT WAS REMOVED WITH THE GUIDEWIRE AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989031 ↗
• InjuryDec 29, 2025Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking; Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS VESSEL. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE CATHETER WAS PROPERLY PREPARED, BUT WHEN IT WAS ADVANCED INTO THE BODY, DIFFICULTY WAS ENCOUNTERED AND WHEN THE DEVICE WAS REMOVED, THE TIP OF THE CATHETER FRACTURED. THE DEVICE WAS CUT WITH THE WIRE, AND EVERYTHING WAS REMOVED TOGETHER. 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 23918959 ↗