OptiCross 6Recalls & reported problems across all models

We found 3 models of OptiCross 6 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2017 and Dec 1, 2025 — classified as 1 death, 6 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (22 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 6 problems

OptiCross 6 models

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

• OptiCross 6 H7495181160

  Catheter, ultrasound, intravascular
  1 death44 reports
• OptiCross™ 6 H7495181360

  Catheter, ultrasound, intravascular
  3 reports
• OptiCross 6 H7495181060

  Catheter, ultrasound, intravascular
  1 report

Recent OptiCross 6 adverse event reports

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

• MalfunctionDec 1, 2025Entrapment of Device; Nonstandard Device; Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, IMAGING WAS TURNED ON, AND THE CATHETER WAS ADVANCED SLIGHTLY. SUDDENLY, THE CATHETER BECAME TANGLED AROUND ITSELF. THE CATHETER AND WIRE GOT STUCK, SO THE PHYSICIAN REMOVED THEM. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682544 ↗
• MalfunctionNov 12, 2025Entrapment of Device; Material Deformation; Physical Resistance/Sticking; Entrapment of Device; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED AND THE VESSEL WAS OCCLUDED. THE 90% STENOSED TARGET LESION AS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. FOLLOWING STENTING, THE OPTICROSS WAS ADVANCED AGAIN, BUT WAS DIFFICULT TO REMOVE AND VESSEL OCCLUSION WAS NOTED. THE OPTICROSS AND GUIDEWIRE WERE REMOVED TOGETHER, AND THE WIRE BROKE IN THE MID-SECTION. THE VESSEL WAS BALLOONED AND THE PROCEDURE CONTINUED AND THE LAD WAS SUCCESSFULLY OPENED. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533475 ↗
• MalfunctionOct 30, 2025Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS 6 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WRAPPED AROUND THE WIRE AND BOTH HAD TO BE REMOVED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424680 ↗
• MalfunctionOct 1, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED VIA MEDWATCH 3600840000-2024-8101 THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR AN ULTRASOUND EXAMINATION OF THE TARGET LESION. THE IVUS CATHETER BEGAN TO SPIN THE NON-BOSTON SCIENTIFIC GUIDEWIRE. BOTH DEVICES WERE REMOVED TOGETHER BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO COMPLICATIONS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343993 ↗
• MalfunctionSep 10, 2024

  MIDDLE AGED FEMALE WITH RECENT ONSET OF CHEST PAIN. PROCEDURE: L AND R CARDIAC CATHETERIZATION WITH PERCUTANEOUS INTERVENTION. THE IVUS (INTRAVASCULAR ULTRASOUND) CATHETER STARTED TO SPIN THE RUN THROUGH WIRE. BOTH WERE REMOVED TOGETHER. A NEW ONE OF EACH (IVUS AND RUN THROUGH) USED FOR PROCEDURE WITHOUT KNOWN INJURY. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179732 ↗
• InjurySep 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT PRESENTED FOR A HIGH RISK, CHRONIC TOTAL OCCLUSION PERCUTANEOUS CORONARY INTERVENTION IN A SAPHENOUS VEIN GRAFT TO CIRCUMFLEX AND A CHRONIC TOTAL OCCLUSION IN THE OBTUSE MARGINAL BRANCH. POST STENTING, THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION. THE PHYSICIAN THINKS THE TIP OF THE CATHETER CAUGHT A PIECE OF PLAQUE AND WHEN THE DEVICE WAS REMOVED WITH DIFFICULTY, BY PULLING, THE CATHETER DISSECTED THE LEFT MAIN. THE DISSECTION WAS STENTED OVER. THE PATIENT WAS FINE AND FULLY RECOVERED.

  Patient problems: Vascular Dissection

  MAUDE report 20138572 ↗
• InjurySep 4, 2024Detachment 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 A CATHETER ISSUE OCCURRED. THE GREATER THAN 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX ARTERY (LCX). THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. AFTER A RUN WAS PERFORMED, AN ATTEMPT WAS MADE TO REMOVE THE CATHETER, BUT IT REMAINED HUNG UP IN THE LEFT MAIN. SEVERAL ATTEMPTS WERE MADE TO PULL BACK THE DEVICE, BUT IT WOULD NOT COME BACK INTO THE 6F GUIDE CATHETER. AN ATTEMPT WAS THEN MADE TO REMOVE THE ENTIRE SYSTEM, INCLUDING THE WIRE, BUT A SNAP WAS HEARD IN THE IVUS CATHETER. THE MAJORITY OF THE OPTICROSS 6 WAS REMOVED, BUT WHEN FLUOROSCOPY WAS PERFORMED, THE RADIOPAQUE PORTION OF THE CATHETER COULD BE VISUALIZED IN THE LEFT MAIN, STILL ON THE WIRE. THE DEVICE FRAGMENT COULD NOT COME BACK ANY FURTHER THAN THE DISTAL LEFT MAIN. ANOTHER WIRE WAS THAN RUN NEXT TO THE DETACHED FRAGMENT AND A BALLOON WAS SENT DOWN THE VESSEL IN A FAILED ATTEMPT TO PIN THE FRAGMENT FOR REMOVAL. THE DECISION WAS MADE TO INSTEAD STENT THE DETACHED FRAGMENT, BUT SINCE DIFFERENT EQUIPMENT WAS NEEDED TO COMPLETE THE PR

  Patient problems: Foreign Body In Patient

  MAUDE report 20135786 ↗
• MalfunctionJul 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH HISTORY OF CHEST PAIN AND POSITIVE STRESS TEST. THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PTCA, THE IVUS (INTRAVASCULAR ULTRASOUND) CATHETER WRAPPED AROUND WIRE. THE ENTIRE SYSTEM HAD TO BE REMOVED (WIRE, IVUS, GUIDE CATHETER, AND SHEATH.) NO KNOWN HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669627 ↗
• MalfunctionJun 11, 2024

  ELDERLY MALE WITH HISTORY OF CHEST PAIN AND POSITIVE STRESS TEST. PROCEDURE: PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY). DURING THE PTCA. THE IVUS (INTRAVASCULAR ULTRASOUND) CATHETER WRAPPED AROUND WIRE. THE ENTIRE SYSTEM HAD TO BE REMOVED. (WIRE, IVUS, GUIDE CATHETER, AND SHEATH.)NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508894 ↗
• MalfunctionDec 28, 2023Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT IMAGING WINDOW FAILURE TO ROTATE OCCURRED. THE OPTI CROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AFTER THE CATHETER WAS PREPARED, THE MOTOR DRIVE UNIT WAS STARTED BUT THE INTRAVASCULAR ULTRASOUND DRIVE SHAFT DID NOT SPIN. A FEW RECONNECTIONS WERE DONE BUT THE DEVICE STILL DID NOT SPIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE IMAGING WINDOW WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411521 ↗
• InjuryDec 19, 2023Retraction Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Retraction Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION AND THE CATHETER AND THE SLED WERE PREPARED APPROPRIATELY. THE CATHETER WAS INSERTED AND WHEN PULLBACK WAS ATTEMPTED, THE CATHETER WOULD NOT PULLBACK. THE MOTOR DRIVE UNIT WAS REMOVED AND REINSERTED INTO THE SLED, BUT PULLBACK WOULD NOT START. A NEW SLED WAS OPENED AND PRE AND POST IVUS FOR THE LAD WERE PERFORMED. THE CIRCUMFLEX ARTERY WAS ALSO DISEASED AND WAS WIRED. WHEN THE OPTICROSS CATHETER WAS INSERTED, THE TRANSDUCER WOULD NOT ADVANCE OUT OF THE GUIDE CATHETER. THE PATIENT STARTED TO HAVE CHEST PAIN, SO THE CATHETER WAS REMOVED, AND AN ANGIOGRAM WAS TAKEN. AIR EMBOLISM WAS OBSERVED, AND THE LAD HAD NO BLOOD FLOW. THE PATIENT WAS GIVEN VASODILATORS AND WITHIN A FEW MINUTES THE LAD WAS OPEN, AND THE PATIENT RECOVERED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT IVUS. AFTER THE CASE, THE CATHETER WAS INSPECTED, AND IT WAS NOTED THAT A PART NEAR THE HUB WAS BROKEN WHICH STOPPED THE SLED F

  Patient problems: Air Embolism; Chest Pain; Reduced Blood Flow

  MAUDE report 18358579 ↗
• MalfunctionNov 22, 2023Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2023. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION, BUT THE IMAGE WAS COMPLETELY BLACK AFTER MULTIPLE FLUSHES AND RECONNECTIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE IMAGING WINDOW AND IMAGING CORE WERE TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193877 ↗
• MalfunctionOct 3, 2023Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AN OPTICROSS 6 CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. WHEN THE CATHETER WAS BEING PULLED BACK AFTER THE IVUS RUN WAS COMPLETED, THE GUIDEWIRE WAS STUCK IN THE LUMEN. THE ENTIRE GUIDEWIRE WAS PULLED FROM THE VESSEL AND BECAME DAMAGED. THE TIP OF THE CATHETER WAS ALSO NOTED TO BE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861763 ↗
• MalfunctionAug 4, 2023

  ELDERLY FEMALE WITH HISTORY OF CAD (CORONARY ARTERY DISEASE). PROCEDURE: HEART CATH WITH PCI (PERCUTANEOUS CORONARY INTERVENTION). THE MOTOR MALFUNCTIONED AND WOULD NOT WORK. ANOTHER ONE USED WITHOUT INCIDENT. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457973 ↗
• MalfunctionJul 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DEVICE TWIST OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. AN OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER WRAPPED ITSELF AROUND THE GUIDEWIRE. THE CATHETER AND WIRE HAD TO BE REMOVED TOGETHER AS A UNIT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344242 ↗

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