ACIST Kodama® Coronary Imaging Catheter 017788Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10841716100755), received between Oct 27, 2017 and Mar 27, 2025 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Break; Break

  DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, USING THE ACIST HIGH-DEFINITION INTRAVASCULAR ULTRASOUND (IVUS) KODAMA CATHETER, THE TIP OF THE CATHETER FRACTURED WITHIN THE BOSTON SCIENTIFIC GUIDE WIRE. THERE WERE NO REPORTED ADVERSE CLINICAL EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707729 ↗
• InjuryMar 7, 2025Break; Break

  DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, USING THE ACIST HIGH-DEFINITION INTRAVASCULAR ULTRASOUND (IVUS) KODAMA CATHETER, THE TIP OF THE CATHETER FRACTURED WITHIN THE PATIENT'S VASCULATURE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE CATHETER TIP BUT WAS UNSUCCESSFUL. THERE WERE NO REPORTED ADVERSE CLINICAL EFFECTS TO THE PATIENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549546 ↗
• InjuryJun 25, 2024Break; Break

  ON MAY 28, 2024, ACIST RECEIVED INFORMATION OF THIS EVENT VIA A USER FACILITY MEDWATCH, REPORT NUMBER MW5154670. THE USER FACILITY REPORTED THE FOLLOWING: DURING A CARDIAC CATHETERIZATION AND INTRAVASCULAR ULTRASOUND WITH THE ACIST HIGH-DEFINITION INTRAVASCULAR ULTRASOUND (IVUS) SYSTEM, WHEN THE KODAMA CATHETER WAS REMOVED FROM THE PATIENT'S CORONARY ARTERY, THE ORANGE TIP FELL OFF AND STUCK ON THE INTERVENTIONAL WIRE INSIDE THE CORONARY ARTERY. THE MEDICAL PROFESSIONAL INSERTED A SNARE, AND THE CATHETER PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S CORONARY ARTERY. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608939 ↗
• MalfunctionApr 16, 2024Fracture; Fracture

  ON (B)(6) 2024, THE USER FACILITY REPORTED THAT THE TIPS OF TWO ACIST HIGH DEFINITION INTRAVASCULAR ULTRASOUND (IVUS) KODAMA CATHETERS HAD BROKEN AND THAT THE CATHETERS HAD NOT BEEN USED ON A PATIENT. ACIST REQUESTED ADDITIONAL INFORMATION ON THE EVENT, AND ON MARCH 5, 2024 THE USER FACILITY REPORTED THAT THE TIP OF ONE KODAMA CATHETER WAS BROKEN AFTER IT WAS USED IN A PATIENT DURING AN IVUS PROCEDURE. THE USER FACILITY REPORTED THAT THIS WAS NOT A ROUTINE IVUS PROCEDURE. THE PATIENT HAD AN OCCLUDED STENT AND PERIPHERAL WAS USED TO OBSERVE, AND THEN THE PHYSICIAN DECIDED TO PERFORM IVUS. THE PHYSICIAN STARTED THE IVUS PROCEDURE WITH AN 0.18 WIRE AND NAVI. THEN THE PHYSICIAN SWITCHED TO A DIFFERENT WIRE (PLATINUM PLUS) TO ATTEMPT TO GET THE KODAMA CATHETER OVER BUT THE PLATINUM PLUS WAS PROLAPSING. THE PHYSICIAN KEPT THE KODAMA CATHETER WITHIN THE PATIENT VASCULATURE AND THEN USED ANOTHER CATHETER TO KEEP THE WIRE FROM PROLAPSING AND TO KEEP MOVING FORWARD WITH THE KODAMA CATHETER. WHEN THIS WASN'T WORKING, THE PHYSICIAN TRIED TO PULL THE KODAMA CATHETER OFF THE WIRE. THE PHYSICIAN REMOVED THE WIRE AND CATHETERS FROM THE PATIENT AND FOUND THE KODAMA CATHETER TIP HAD BROKEN. IT IS PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116802 ↗
• MalfunctionJan 10, 2024

  KODAMA IVUS CATHETER STOPPED WORKING DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484214 ↗
• MalfunctionOct 31, 2023

  ULTRASOUND CATHETER PLACED INTO CORONARY ARTERY. AS THE CATHETER WAS PULLING BACK, THE CATHETER FAILED TO PROVIDE IMAGE. REMOVED FROM BODY AND PROVIDED A NEW ULTRASOUND CATHETER WAS INSERTED INTO THE CORONARY ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038907 ↗
• MalfunctionAug 22, 2023

  ACIST IVUS CATHETER WORKED APPROPRIATELY FOR 3 RUNS AND ON THE 4TH RUN, FAILED TO IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595135 ↗
• MalfunctionAug 21, 2023

  DURING THE IVUS ULTRASOUND THE IMAGES WHERE VERY DARK, AND HARD TO SEE AND EVENTUALLY NO LONGER VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583784 ↗
• InjuryFeb 2, 2023Break; Break

  DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE USING THE ACIST KODAMA CATHETER, THE TIP BROKE WITHIN PATIENT. THE TIP WAS REMOVED BY THE PHYSICIAN AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287216 ↗
• MalfunctionJan 4, 2023Defective Device

  DEVICE INSERTED INTO CORONARY ARTERY, WHICH FAILED AND DID NOT OPERATE. DEVICE MALFUNCTIONED IN THE HEART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093999 ↗
• InjuryDec 2, 2022Fracture; Fracture

  DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE USING THE ACIST HDI HD IVUS SYSTEM WITH KODAMA CATHETER, THE TIP OF THE KODAMA CATHETER BROKE AND WAS VISIBLE ON FLUOROSCOPY. THE KODAMA CATHETER WAS REMOVED AND THE CATHETER TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910829 ↗
• MalfunctionNov 9, 2022Device Dislodged or Dislocated

  DURING A CARDIAC CATHETERIZATION, THE TIP OF A ACIST MEDICAL IVUS CATHETER DISLODGED AND WAS SEEN ON FLUORO. CATHETER WAS REMOVED AND THE TIP WAS RETRIEVED WITH NO HARM TO PATIENT. SECOND CATHETER WAS USED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759409 ↗
• InjuryJun 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING AN ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE USING THE ACIST HDI HD IVUS SYSTEM WITH KODAMA CATHETER, A THROMBUS HAD FORMED AT THE LESION SITE. THE PATIENT WAS ADMINISTERED TIROFIBAN VIA INJECTION, THE LESION WAS THEN STENTED, AND A FINAL ANGIOGRAPHY WAS PERFORMED. THERE WAS NO RESIDUAL SIGNS OF STENOSIS OR THROMBOSIS AT THE STENT SITE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14778039 ↗
• InjuryJun 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING AN ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE USING THE ACIST HDI HD IVUS SYSTEM WITH KODAMA CATHETER, THE POST IVUS ANGIO SHOWED FORMATION OF THROMBUS AT THE LESION SITE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT WAS ADMINISTERED TIROFIBAN AND NICORANDIL VIA INJECTION WITH SUBSEQUENT DEVELOPMENT OF BRADYCARDIA AND CHEST PAIN. SUBSEQUENTLY, THE LESION WAS STENTED. THE FINAL ANGIO WITH AND WITHOUT WIRE SHOWED NO RESIDUAL STENOSIS AT THE STENT SITE AND NO THROMBUS, DISSECTION, INTIMAL FLAP WITH DISTAL THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) III FLOW.

  Patient problems: Bradycardia; Chest Pain; Thrombosis/Thrombus

  MAUDE report 14778033 ↗
• InjuryDec 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE USING THE ACIST HIGH-DEFINITION INTRAVASCULAR ULTRASOUND (IVUS) SYSTEM, MODEL HDI, AND ACIST KODAMA INTRAVASCULAR ULTRASOUND CATHETER, THE KODAMA CATHETER WORKED FINE WHILE PERFORMING THE FIRST FEW PULLBACKS IN THE RIGHT CORONARY ARTERY (RCA). THE USER EXPERIENCED RESISTANCE WHILE TRYING TO ADVANCE AND REMOVE THE KODAMA CATHETER FROM THE OBTUSE MARGINAL (OM) ARTERY AND NO PULLBACKS WERE PERFORMED. SUBSEQUENTLY, ANOTHER RUN WAS ATTEMPTED IN THE LEFT CIRCUMFLEX (LCX) ARTERY, BUT NO IMAGE COULD BE OBTAINED. THE CATHETER WAS REMOVED FROM THE LCX AND RESISTANCE WAS ALSO ENCOUNTERED. AT THE END OF THE CASE, A DISSECTION WAS DISCOVERED IN THE LEFT MAIN ARTERY.

  Patient problems: Vascular Dissection

  MAUDE report 12988965 ↗
• InjuryOct 12, 2020Fracture; Break; Fracture; Physical Resistance/Sticking

  USER FACILITY REPORT, DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, USING THE ACIST HDI HIGH-DEFINITION INTRAVASCULAR ULTRASOUND (IVUS) SYSTEM AND ACIST KODAMA INTRAVASCULAR ULTRASOUND CATHETER ON A PATIENT WITH NON-ST-SEGMENT MYOCARDIAL INFARCTION, THE KODAMA CATHETER BECAME ENTRAPPED, AND DESPITE ROTATION AND GENTLE WITHDRAWAL, THE TIP OF THE KODAMA CATHETER BROKE OFF AND WAS RETAINED IN THE PATIENT'S LEFT ANTERIOR DESCENDING ARTERY (LAD). SUBSEQUENTLY, THE PATIENT HAD THROMBOSIS OF THE LEFT MAIN CORONARY ARTERY (LMCA), VENTRICULAR FIBRILLATION, CARDIAC ARREST, AND HYPOTENSION. AFTER HEMODYNAMIC SUPPORT AND CARDIOPULMONARY RESUSCITATION (CPR), THE PATIENT'S LMCA WAS REOPENED AND STENTED. IMAGING SUGGESTED THAT AN EXTRUDED PIECE OF CATHETER FRAGMENT HAD BEEN PULLED BACK INTO THE LMCA. THE CATHETER PIECE WAS STENTED. THE PATIENT WAS IN CRITICAL CONDITION POST THE EVENT.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Myocardial Infarction; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 10668217 ↗
• InjuryNov 28, 2017Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT ON (B)(6) 2017 DURING A PROCEDURE UTILIZING THE ACIST HDI HIGH-DEFINITION INTRAVASCULAR ULTRASOUND (IVUS) SYSTEM AND ACIST KODAMA INTRAVASCULAR ULTRASOUND CATHETER IN A TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY (RCA), THE TIP OF THE CATHETER WAS DETACHED INSIDE THE PATIENT. THE LESION WAS PRE-DILATED WITH A BALLOON CATHETER; HOWEVER, THE PHYSICIAN WAS NOT ABLE TO CROSS THE LESION. WHEN THE KODAMA WAS WITHDRAWN FROM THE PATIENT, THE DISTAL TIP OF THE CATHETER WAS MISSING. THE PHYSICIAN CONFIRMED ON ANGIOGRAPHY THAT THE TIP WAS STILL IN THE PATIENT'S BODY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE TIP WITH A SNARE AND GUIDEWIRE SEVERAL TIMES, BUT WAS UNSUCCESSFUL AND THE TIP WAS LEFT UNTREATED IN THE PATIENT. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AT THEIR REQUEST ON (B)(6) 2017. A PHYSICIAN AT THIS HOSPITAL WAS ABLE TO SNARE THE TIP AND PERCUTANEOUS INTERVENTION (PCI) WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7065571 ↗
• InjuryOct 27, 2017Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE UTILIZING THE ACIST HDI HIGH-DEFINITION INTRAVASCULAR ULTRASOUND (IVUS) SYSTEM AND ACIST KODAMA INTRAVASCULAR ULTRASOUND CATHETER IN A HIGHLY CALCIFIED LEFT MAIN ARTERY, THE TIP OF THE KODAMA WAS DETACHED INSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY WITH THIS EVENT. THE PHYSICIAN USED A SNARE IN ATTEMPT TO RETRIEVE THE TIP, BUT WAS UNSUCCESSFUL. THE TIP WAS SUCCESSFULLY TACKED TO THE VESSEL WALL WITH A STENT. THE PHYSICIAN REPORTED THAT THREE BALLOONS HAD RUPTURED IN THE CALCIFIED, TORTUOUS LEFT MAIN PRIOR TO IVUS.

  Patient problems: Foreign Body In Patient

  MAUDE report 6983535 ↗