RUNTHROUGH 25-5211Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04987350734709), received between Nov 23, 2022 and Jan 1, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 1, 2025Material Fragmentation; Material Fragmentation

  TERUMO MEDICAL RECEIVED AN FDA UF/IMPORTER REPORT # (B)(4). THE EVENT DESCRIPTION STATES: DURING A STENT/ANGIOPLASTY PROCEDURE, PART OF A GUIDE WIRE SHEARED OFF IN THE AORTA. THE REMNANTS OF THE WIRE WERE SUCCESSFULLY SNARED AND RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21050640 ↗
• InjuryJan 1, 2025Material Fragmentation; Material Fragmentation

  TERUMO MEDICAL RECEIVED AN FDA UF/IMPORTER REPORT # (B)(4). THE EVENT DESCRIPTION STATES: DURING A STENT/ANGIOPLASTY PROCEDURE, PART OF A GUIDE WIRE SHEARED OFF IN THE AORTA. THE REMNANTS OF THE WIRE WERE SUCCESSFULLY SNARED AND RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21050639 ↗
• InjuryJul 23, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT WHILE ATTEMPTING TO FIX A RIGHT CORONARY ARTERY (RCA) AND POSTERIOR LEFT BRANCH (PLB) BRANCH, THE DOCTOR PLACED THREE (3) STENTS AND HAD TWO (2) WIRES IN THE VESSEL. AFTER THE DEPLOYMENT OF THE 3RD STENT IN THE DRCA, THE DOCTOR WENT TO PULL THE WIRE OUT AND FELT SOME RESISTANCE. AFTER THE WIRE WAS REMOVED, HE NOTICED THAT THE TIP OF THE WIRE HAD DETACHED FROM THE BODY OF THE WIRE. THEY HAD TO SNARE OUT THE WIRE TIP AND THE PATIENT WAS STABLE. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA_ OF THE RCA/PLB. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19809048 ↗
• InjuryJul 23, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT WHILE ATTEMPTING TO FIX A RIGHT CORONARY ARTERY (RCA) AND POSTERIOR LEFT BRANCH (PLB) BRANCH, THE DOCTOR PLACED THREE (3) STENTS AND HAD TWO (2) WIRES IN THE VESSEL. AFTER THE DEPLOYMENT OF THE 3RD STENT IN THE DRCA, THE DOCTOR WENT TO PULL THE WIRE OUT AND FELT SOME RESISTANCE. AFTER THE WIRE WAS REMOVED, HE NOTICED THAT THE TIP OF THE WIRE HAD DETACHED FROM THE BODY OF THE WIRE. THEY HAD TO SNARE OUT THE WIRE TIP AND THE PATIENT WAS STABLE. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA OF THE RCA/PLB. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19808586 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED IZANAI WIRE WAS ADVANCED TO DISTAL RIGHT CORONARY ARTERY (RCA) AND PARKED IN A BRANCH VESSEL. THIS LED TO A SMALL PERFORATION. THE PATIENT WAS NOT HARMED, AND THE CASE WAS COMPLETED SUCCESSFULLY. NO BLOOD LOSS WAS REPORTED. THE EVENT RESULTS DID RESULT IN PATIENT INJURY AND MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THERE IS NO DIRECT CLAIM THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO A PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 30 APR 2024: THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RCA. THE PATIENT WAS STABLE AND DOING WELL.

  Patient problems: Perforation

  MAUDE report 19352888 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE IZANAI WIRE WAS IN THE FIRST DIAGONAL, WITH THE TIP PROLAPSED. THE PHYSICIAN THEN DID A BALLOON ANGIOPLASTY, THE WIRE STRAIGHTENED OUT, AND PERFORATED THE DISTAL END OF THE FIRST DIAGONAL. IT WAS OBSERVED THAT THE PATIENT CODED. A PERICARDIOCENTESIS WAS DONE, DRAINED, AN ANGIOGRAM WAS PERFORMED, AND A NESTER COIL WAS PLACED. THE PATIENT WAS HYPOTENSIVE 60/40. THEY WAITED; HOWEVER, THE PATIENT WAS STILL BLEEDING, THEREFORE THEY PLACED A SECOND NESTER COIL. THE ESTIMATED BLOOD LOSS WAS GREATER THAN 250CC'S, 3,000CC'S. THE CASE WAS STRAIGHTFORWARD, NON-STEMI. THE TYPE OF PROCEDURE WAS A PCI AND STENT. RELEVANT TESTS AND LAB RESULTS INCLUDING DATES ARE AS FOLLOWED, FOUR (4) CATHETERIZATIONS - ONE (1) ON THURSDAY (B)(6), TWO (2) OVERNIGHT, ONE (1) IN THE EVENING ON (B)(6). THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE WAS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 01NOV2023: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON FRIDAY (B)

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 18170377 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE IZANAI WIRE WAS IN THE FIRST DIAGONAL, WITH THE TIP PROLAPSED. THE PHYSICIAN THEN DID A BALLOON ANGIOPLASTY, THE WIRE STRAIGHTENED OUT, AND PERFORATED THE DISTAL END OF THE FIRST DIAGONAL. IT WAS OBSERVED THAT THE PATIENT CODED. A PERICARDIOCENTESIS WAS DONE, DRAINED, AN ANGIOGRAM WAS PERFORMED, AND A NESTER COIL WAS PLACED. THE PATIENT WAS HYPOTENSIVE 60/40. THEY WAITED; HOWEVER, THE PATIENT WAS STILL BLEEDING, THEREFORE THEY PLACED A SECOND NESTER COIL. THE ESTIMATED BLOOD LOSS WAS GREATER THAN 250CC'S, 3,000CC'S. THE CASE WAS STRAIGHTFORWARD, NON-STEMI. THE TYPE OF PROCEDURE WAS A PCI AND STENT. RELEVANT TESTS AND LAB RESULTS INCLUDING DATES ARE AS FOLLOWED, FOUR (4) CATHETERIZATIONS - ONE (1) ON THURSDAY (B)(6), TWO (2) OVERNIGHT, ONE (1) IN THE EVENING ON (B)(6). THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE WAS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 01NOV2023: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON FRIDAY (B)

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 18170376 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE RUNTHROUGH DEVICE INVOLVED WAS USED DURING A MULTIPLE VESSEL CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI) SHOCKWAVE BALLOON ANGIOPLASTY. A DISTAL LEFT ANTERIOR (LAD) PERFORATION WAS IDENTIFIED. VESSEL PERFORATION REQUIRED EMBOLIZATION AND SURGICAL INTERVENTION. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). THERE WAS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: Embolism/Embolus; Perforation of Vessels

  MAUDE report 18161541 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE RUNTHROUGH DEVICE INVOLVED WAS USED DURING A MULTIPLE VESSEL CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI) SHOCKWAVE BALLOON ANGIOPLASTY. A DISTAL LEFT ANTERIOR (LAD) PERFORATION WAS IDENTIFIED. VESSEL PERFORATION REQUIRED EMBOLIZATION AND SURGICAL INTERVENTION. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). THERE WAS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: Embolism/Embolus; Perforation of Vessels

  MAUDE report 18161511 ↗
• InjuryAug 17, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE INVOLVED DEVICE WAS USED DURING A COMPLEX RIGHT CORONARY CHRONIC TOTAL OCCLUSION (CTO) PERCUTANEOUS CORONARY INTERVENTION (PCI). RIGHT FEMORAL ACCESS WAS WITH A 7 FRENCH 45 CM PINNACLE DESTINATION CCV WITH 7 FR GUIDELINER, 6 FR AL1 CATHETER, 180 CM IZANAI WIRE, WITH UNKNOWN BUDDY WIRE IN PLACE. MIDWAY THROUGH THE PROCEDURE, THE MD STATED THAT THE IZANAI WIRE WAS STUCK. THE MD WAS UNABLE TO ADVANCE OR RETRACT THE IZANAI WIRE, ALL OTHER PRODUCTS AND INSTRUMENTS THAT WERE IN PLACE MOVED FREELY. THE BUDDY WIRE WAS REMOVED TO TRY AND FREE UP THE IZANAI WIRE WITHOUT SUCCESS. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE MD INTRODUCED A CORSAIR PRO. ADDITIONAL ATTEMPTS TO REMOVE THE IZANAI WIRE WERE UNSUCCESSFUL, DESPITE THE CORSAIR PRO IN PLACE. THE MD WAS ULTIMATELY ABLE TO SUCCESSFULLY REMOVE THE IZANAI WIRE BY SIGNIFICANTLY PULLING WITH MORE FORCE. A SMALL DISSECTION WAS NOTED, THE MD STATED THAT DUE TO MULTIPLE BALLOON INFLATIONS AND OTHER INTERVENTIONS IN THE SAME AREA, THE ROOT CAUSE OF THE DISSECTION COULD NOT BE CONCLUSIVELY DETERMINED TO BE THE IZANAI WIRE. UPON ASSESSMENT OF THE WIRE ONCE IT HAD BEEN REMOVED, TWO DISTINCT AREAS OF ROUGHNESS WERE

  Patient problems: Vascular Dissection

  MAUDE report 17569166 ↗
• InjuryAug 17, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE INVOLVED DEVICE WAS USED DURING A COMPLEX RIGHT CORONARY CHRONIC TOTAL OCCLUSION (CTO) PERCUTANEOUS CORONARY INTERVENTION (PCI). RIGHT FEMORAL ACCESS WAS WITH A 7 FRENCH 45 CM PINNACLE DESTINATION CCV WITH 7 FR GUIDELINER, 6 FR AL1 CATHETER, 180 CM IZANAI WIRE, WITH UNKNOWN BUDDY WIRE IN PLACE. MIDWAY THROUGH THE PROCEDURE, THE MD STATED THAT THE IZANAI WIRE WAS STUCK. THE MD WAS UNABLE TO ADVANCE OR RETRACT THE IZANAI WIRE, ALL OTHER PRODUCTS AND INSTRUMENTS THAT WERE IN PLACE MOVED FREELY. THE BUDDY WIRE WAS REMOVED TO TRY AND FREE UP THE IZANAI WIRE WITHOUT SUCCESS. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE MD INTRODUCED A CORSAIR PRO. ADDITIONAL ATTEMPTS TO REMOVE THE IZANAI WIRE WERE UNSUCCESSFUL, DESPITE THE CORSAIR PRO IN PLACE. THE MD WAS ULTIMATELY ABLE TO SUCCESSFULLY REMOVE THE IZANAI WIRE BY SIGNIFICANTLY PULLING WITH MORE FORCE. A SMALL DISSECTION WAS NOTED, THE MD STATED THAT DUE TO MULTIPLE BALLOON INFLATIONS AND OTHER INTERVENTIONS IN THE SAME AREA, THE ROOT CAUSE OF THE DISSECTION COULD NOT BE CONCLUSIVELY DETERMINED TO BE THE IZANAI WIRE. UPON ASSESSMENT OF THE WIRE ONCE IT HAD BEEN REMOVED, TWO DISTINCT AREAS OF ROUGHNESS WERE

  Patient problems: Vascular Dissection

  MAUDE report 17569165 ↗
• InjuryNov 23, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED A POTENTIAL CORONARY PERFORATION, THERE WAS NO ANGIOGRAPHIC EVIDENCE DURING THE CASE. THE DOCTOR PERFORMED A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE MID LAD OVER A IZANAI 180 CM WIRE. THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY. AFTER ASSESSING THE PATIENT, THE DOCTOR BELIEVED THE BLEED TO BE INTO THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE FLUID. THE PATIENT BECAME STABLE AND WAS RELEASED. THE DOCTOR DOES NOT DEEM THIS TO BE CAUSED BY A DEFECT OF THE WIRE. THE WIRE DID NOT SEPARATE OR MALFUNCTION IN ANYWAY. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. THE EVENT OCCURRED INTRA-OPERATIVE. PERICARDIOCENTESIS WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THERE WAS NO ANGIOGRAPHIC EVIDENCE OF AN INCIDENT. THE PATIENT CODED A FEW HOURS AFTER THE PROCEDURE. A NEEDLE WAS USED TO DRAIN THE FLUID OUT OF THE PERICARDIUM. THE PHYSICIAN STATED THE INCIDENT COULD HAVE ONLY BEEN CAUSED BY A WIRE PERFORATION. A BOSTON SCIENCE BALLOON AND STENT WERE USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 15853750 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A POTENTIAL CORONARY PERFORATION, THERE WAS NO ANGIOGRAPHIC EVIDENCE DURING THE CASE. THE DOCTOR PERFORMED A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE MID LAD OVER A IZANAI 180 CM WIRE. THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY. AFTER ASSESSING THE PATIENT, THE DOCTOR BELIEVED THE BLEED TO BE INTO THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE FLUID. THE PATIENT BECAME STABLE AND WAS RELEASED. THE DOCTOR DOES NOT DEEM THIS TO BE CAUSED BY A DEFECT OF THE WIRE. THE WIRE DID NOT SEPARATE OR MALFUNCTION IN ANYWAY. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. THE EVENT OCCURRED INTRA-OPERATIVE. PERICARDIOCENTESIS WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 03 NOV 2022: THERE WAS NO ANGIOGRAPHIC EVIDENCE OF AN INCIDENT. THE PATIENT CODED A FEW HOURS AFTER THE PROCEDURE. A NEEDLE WAS USED TO DRAIN THE FLUID OUT OF THE PERICARDIUM. THE PHYSICIAN STATED THE INCIDENT COULD HAVE ONLY BEEN CAUSED BY A WIRE PERFORATION. A BOSTON SCIENCE BALLOON AND STENT WERE USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 15853735 ↗