OptiCross 18Recalls & reported problems across all models

We found 2 models of OptiCross 18 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 203 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2018 and Feb 3, 2026 — classified as 32 injuries, 171 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (68 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 18 problems

OptiCross 18 models

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

• OptiCross 18 H7493932800180

  Catheter, ultrasound, intravascular
  186 reports
• OptiCross 18 H7493932700180

  Catheter, ultrasound, intravascular
  17 reports

Recent OptiCross 18 adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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, 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 ↗
• 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 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports