OptiCrossRecalls & reported problems across all models

We found 4 models of OptiCross by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 547 adverse event reports in the FDA's MAUDE database, received between Jan 11, 2017 and Sep 4, 2026 — classified as 6 deaths, 26 injuries, 515 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (172 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported OptiCross problems

OptiCross models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OptiCross H749518100

  Catheter, ultrasound, intravascular
  2 deaths457 reports
• OptiCross H749518120

  Catheter, ultrasound, intravascular
  3 deaths58 reports
• OptiCross H749518110

  Catheter, ultrasound, intravascular
  1 death27 reports
• OptiCross™ H749518130

  Transducer, ultrasonic, diagnostic
  5 reports

Recent OptiCross adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Leak/Splash; Air/Gas in Device

  It was reported that catheter issue occurred.An OptiCross imaging catheter was selected for the ultrasound examination of the target lesion. During preparation, the technician noticed that the flushing tubing was leaking, which prevented proper air removal. The procedure was completed with another of same device. The patient remained stable after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614139 ↗
• InjurySep 3, 2026Air/Gas in Device

  It was reported that a catheter issue occurred resulting in patient complications.The patient presented with chest pain. The OptiCross imaging catheter was selected for ultrasound examination of the target lesion. The catheter was flushed while inside the patient, which resulted in air embolism and slow flow. No actions were taken. The procedure was completed with another OptiCross catheter. The patient outcome was unknown.

  Patient problems: Air Embolism; Reduced Blood Flow

  MAUDE report 50588268 ↗
• InjuryAug 3, 2026Entrapment of Device; Detachment of Device or Device Component

  It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery. An OptiCross imaging catheter was advanced for intravascular ultrasound (IVUS) examination of the target lesion. During the procedure, the catheter was advanced over the guidewire to the distal segment for IVUS examination. The patients vessels were extremely tortuous and stenotic, with multiple segments exhibiting angulations greater than 60 degrees. Automatic pullback of the IVUS catheter was not possible, and catheter entrapment with a potential tip fracture was suspected. Attempts to retrieve the catheter by the operator were unsuccessful. The fractured catheter tip remained in the patient, and multiple stents were deployed to completely cover the lesion and secure the fractured tip against the vessel wall. Post dilation was performed repeatedly using a non-compliant balloon to ensure adequate stent apposition. Intensified antiplatelet therapy was administered after the procedure. The procedure was completed with another of the same device. The patient was stable following the procedure. There were no patient

  Patient problems: Foreign Body In Patient

  MAUDE report 50116239 ↗
• MalfunctionJun 29, 2026Difficult to Flush; Unable to Obtain Readings; Failure to Advance; Air/Gas in Device

  It was reported that a catheter issue occurred.The OptiCross imaging catheter was selected for intravascular ultrasound examination. During preparation, solution could not be injected through the catheter. The device was examined and evidence indicated that the conduit was blocked, preventing the flush from being performed. Air was observed throughout the catheter and could not be removed. The device did not enter the patient and 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 25659541 ↗
• MalfunctionApr 7, 2026No Display/Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; HOWEVER, THE IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION WAS GOOD, AND NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE IMAGING WINDOW WAS RIPPLED AND THE IMAGING CORE WAS ENTANGLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800529 ↗
• MalfunctionApr 1, 2026No Display/Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11MAR2026. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 96% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER COULD NOT SHOW THE IMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE CATHETER WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758114 ↗
• MalfunctionMar 30, 2026No Display/Image; Poor Quality Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05MAR2026. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, DARK IMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED TWISTED DRIVE CABLE AND THE IMAGING WINDOW HAD RIPPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717584 ↗
• MalfunctionMar 3, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12 FEB 2026. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; HOWEVER, IT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION WAS GOOD, AND NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS ENTANGLED WITH THE GUIDEWIRE CABLE. THE CATHETER WAS TWISTED, AND THE IMAGING WINDOW WAS RIPPLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501041 ↗
• MalfunctionMar 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED, 28 X 3.0MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD). AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION (IVUS) OF THE TARGET LESION. DURING THE PROCEDURE, THE TIP BECAME TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497208 ↗
• MalfunctionFeb 10, 2026Entrapment of Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING THE PREPARATION, THE CATHETER BECAME ENTANGLED WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL AND THE CATHETER AND GUIDEWIRE WERE PULLED OUT TOGETHER AS ONE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307287 ↗
• InjuryFeb 10, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION (IVUS) OF THE TARGET LESION. DURING PROCEDURE, THE GUIDE WIRE WAS KNOTTED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT A 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE GUIDEWIRE USED WAS A NON-BOSTON SCIENTIFIC (NON-BSC) DEVICE. A GUIDE EXTENSION CATHETER WAS USED TO REMOVE THE CATHETER AND WIRE AS ONE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306429 ↗
• MalfunctionFeb 9, 2026No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT ENTRAPPED AIR OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS). DURING PREPARATION, THE INITIAL IMAGE APPEARED NORMAL, BUT SHORTLY AFTERWARD BUBBLES WERE OBSERVED AND THE IMAGE TURNED BLACK AND BECAME NON VIEWABLE. THE CATHETER WAS DIFFICULT TO FLUSH. THREE ATTEMPTS WERE MADE TO FLUSH THE CATHETER TO REMOVE AIR, BOTH INSIDE AND OUTSIDE THE PATIENT, BUT AIR CONTINUED TO APPEAR DURING PULLBACK. RESISTANCE WAS ALSO NOTED WHEN ATTEMPTING TO PUSH FLUID THROUGH THE SYRINGES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300118 ↗
• MalfunctionFeb 9, 2026No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT ENTRAPPED AIR OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS). DURING PREPARATION, THE INITIAL IMAGE APPEARED NORMAL, BUT SHORTLY AFTERWARD BUBBLES WERE OBSERVED AND THE IMAGE TURNED BLACK AND BECAME NON VIEWABLE. THE CATHETER WAS DIFFICULT TO FLUSH. THREE ATTEMPTS WERE MADE TO FLUSH THE CATHETER TO REMOVE AIR, BOTH INSIDE AND OUTSIDE THE PATIENT, BUT AIR CONTINUED TO APPEAR DURING PULLBACK. RESISTANCE WAS ALSO NOTED WHEN ATTEMPTING TO PUSH FLUID THROUGH THE SYRINGES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OPTICROSS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300117 ↗
• MalfunctionFeb 9, 2026No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT ENTRAPPED AIR OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS). DURING PREPARATION, THE INITIAL IMAGE APPEARED NORMAL, BUT SHORTLY AFTERWARD BUBBLES WERE OBSERVED AND THE IMAGE TURNED BLACK AND BECAME NON VIEWABLE. THE CATHETER WAS DIFFICULT TO FLUSH. THREE ATTEMPTS WERE MADE TO FLUSH THE CATHETER TO REMOVE AIR, BOTH INSIDE AND OUTSIDE THE PATIENT, BUT AIR CONTINUED TO APPEAR DURING PULLBACK. RESISTANCE WAS ALSO NOTED WHEN ATTEMPTING TO PUSH FLUID THROUGH THE SYRINGES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300115 ↗
• MalfunctionFeb 5, 2026No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS AIR INSIDE THE CATHETER. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AFTER TAKING THREE FLUSHING ATTEMPTS BEFORE THE DEVICE WAS SUCCESSFULLY FLUSHED, THE CATHETER WAS INSERTED INTO THE PATIENT. THERE WERE BLACK VISUALS AND BUBBLES PRESENT DURING THE RUN. ANOTHER FLUSHING WAS ATTEMPTED, HOWEVER THIS RESULTED IN NO VISUALS. THE CATHETER WAS REMOVED FROM THE PATIENT, AND ANOTHER OPTICROSS CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268437 ↗

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