RUNTHROUGHRecalls & reported problems across all models

We found 7 models of RUNTHROUGH by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 170 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2016 and Jul 27, 2026 — classified as 4 deaths, 145 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (66 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 RUNTHROUGH problems

RUNTHROUGH models

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

• RUNTHROUGH 25-1011

  WIRE, GUIDE, CATHETER
  2 deaths103 reports
• RUNTHROUGH 25-1011

  Wire, guide, catheter
  2 deaths31 reports
• RUNTHROUGH 25-5211

  Wire, guide, catheter
  13 reports
• RUNTHROUGH 25-1013

  WIRE, GUIDE, CATHETER
  10 reports
• RUNTHROUGH 25-3011

  WIRE, GUIDE, CATHETER
  8 reports
• RUNTHROUGH 25-3013

  WIRE, GUIDE, CATHETER
  3 reports
• RUNTHROUGH 25-5011

  Wire, guide, catheter
  2 reports

Recent RUNTHROUGH adverse event reports

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

• DeathJul 27, 2026Material Fragmentation

  Terumo received the following information: It was reported that during percutaneous coronary intervention (PCI) the wire upon removal became entrapped by the stent placed in the distal left anterior descending artery (LAD) and was frayed. A portion of wire remained entrapped in the patient. There was no blood loss.Terumo Medical Corporation received an FDA MedWatch Report on (b)(6) 2026. The event description states: "Patient had heart failure, and had an impella placed in operating room prior to planned coronary angiogram for high risk cornary artery disease.In the cardiac cath lab, during angiogram, the Runthrough white wire, upon removal, became entrapped by the stent placed in the distal left anterior descending artery and was frayed. A portion of the wire remained entrapped in the patient. Retained wire was removed from patient. Wire fracture with retained wire in the LM (Left Main Coronary Artery) into LAD (Left Anterior Descending Artery), some of the wire able to be snared with filament protruding still into the aorta."Additional information was received on 30Jun2026: The wire became entrapped in the distal edge of the distal edge of the stent and became uncoiled upon attem

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 50036062 ↗
• InjuryJul 15, 2026Peeled/Delaminated; Unraveled Material

  TERUMO MEDICAL RECEIVED THE FOLLOWING INFORMATION: DURING A PCI, THE RUNTHROUGH NS 180 CM WIRE WAS USED TO WIRE THE LESION. THE PROXIMAL PORTION OF THE WIRE UNRAVELED AND SHEARED OFF IN THE CIRCUMFLEX PATIENT STARTED HAVING BRADYCARDIA. THE DOCTOR SAW EVIDENCE OF PLAQUE SHIFTING TOO. THEREFORE, AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED TO SEE INSIDE THE VESSEL. A SECOND RUNTHROUGH NS WIRE WAS OPENED AND USED TO FINISH THE CASE. A 3.5X16MM (CORONARY STENT) WAS PLACED TO TACK THE SHEARED OFF WIRE AND PLAQUE TO THE WALL OF THE CIRCUMFLEX AND FLOW WAS RESTORED. THE PATIENT WAS DOING WELL AND WAS NOT HAVING ANY ISSUES AT THAT POINT. NO BLOOD LOSS WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25827440 ↗
• InjuryJul 14, 2026Break; Unintended Deflation

  TERUMO MEDICAL RECEIVED THE FOLLOWING INFORMATION: THE RT GOT JAILED/STUCK BETWEEN STENT AND TISSUE DURING A LEFT HEART CATH (LHC). THE DOCTOR TRIED BALLOONING OVER THE WIRE TO RELEASE; HOWEVER, THAT DID NOT WORK. THE PULLED ON THE RT WIRE AND IT BROKE WIRE OFF AT JUNCTION POINT AS WELL AS STRETCHED WIRE. THE DOCTOR CALLED ANOTHER SURGEON AND THE PATIENT SENT TO SURGERY TO REMOVE THE WIRE; HOWEVER, THERE WERE NO DETAILS ON THE SUCCESS OR EXTENT OF THE REMOVAL. NO BLOOD LOSS WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25813186 ↗
• MalfunctionJul 14, 2026Break; Unintended Deflation

  Patient problems: Foreign Body In Patient

  MAUDE report 25812973 ↗
• MalfunctionJul 9, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25765841 ↗
• DeathJun 30, 2026

  PATIENT HAD HEART FAILURE, AND HAD AN IMPELLA PLACED IN OR PRIOR TO PLANNED CORONARY ANGIOGRAM FOR HIGH RISK CORONARY ARTERY DISEASE. IN THE CARDIAC CATH LAB, DURING ANGIOGRAM, THE RUN THROUGH WHITE WIRE, UPON REMOVAL, BECAME ENTRAPPED BY THE STENT PLACED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY AND WAS FRAYED. A PORTION OF THE WIRE REMAINED ENTRAPPED IN THE PATIENT. RETAINED WIRE WAS REMOVED FROM PATIENT. WIRE FRACTURE WITH RETAINED WIRE IN THE LM (LEFT MAIN CORONARY ARTERY) INTO LAD (LEFT ANTERIOR DESCENDING ARTERY), SOME OF THE WIRE ABLE TO BE SNARED WITH FILAMENT PROTRUDING STILL INTO THE AORTA. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, RUN THROUGH (PER SITE REPORTER).

  Patient problems: Foreign Body In Patient; Unspecified Heart Problem

  MAUDE report 25664207 ↗
• InjuryFeb 12, 2026Material Fragmentation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: A TINY PIECE OF THE RUNTHROUGH WIRE BROKE OFF/CAME OFF WITHIN THE PATIENT DURING THE CORONARY ANGIOGRAM CASE. TO RESOLVE THE ISSUE, THEY ATTEMPTED TO PLASTY WITH BALLOON TO "TRAP" PIECE OF WIRE AND ATTEMPTED TO SNARE. THERE WAS CALCIUM PRESENT IN PATIENT'S ANATOMY WHEN THE WIRE FRAGMENT BROKE OFF. THE CASE WAS SUCCESSFULLY COMPLETED. THE EVENT DID NOT CAUSE ANY HARM, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24326289 ↗
• InjuryFeb 12, 2026Material Fragmentation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: A TINY PIECE OF THE RUNTHROUGH WIRE BROKE OFF/CAME OFF WITHIN THE PATIENT DURING THE CORONARY ANGIOGRAM CASE. TO RESOLVE THE ISSUE, THEY ATTEMPTED TO PLASTY WITH BALLOON TO "TRAP" PIECE OF WIRE AND ATTEMPTED TO SNARE. THERE WAS CALCIUM PRESENT IN PATIENT'S ANATOMY WHEN THE WIRE FRAGMENT BROKE OFF. THE CASE WAS SUCCESSFULLY COMPLETED. THE EVENT DID NOT CAUSE ANY HARM, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24326262 ↗
• InjuryNov 11, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DOCTOR STATED WHEN HE SHAPED THE WIRE THE TIP FEELS LIKE IT BREAKS OR WAS BROKEN. THE TYPE OF PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE FIELD CLINICAL SPECIALIST (FCS) WAS PRESENT FOR THE PROCEDURE ON (B)(6). DURING THE PROCEDURE, THE DOCTOR COMMENTED THAT THE WIRE TIP SEEMED BROKEN WHEN HE WENT TO SHAPE IT. THERE WAS NO HARM CAUSED TO THE PATIENT. THE TIP DID NOT SEPARATE FROM THE WIRE HOWEVER IT DOES FEEL LIKE IT WAS BROKEN. WHEN WAS SHAPED THE WIRE INSTEAD OF THE TIP REPLICATING A NICE CURVE, IT SEEMED TO KINK OR BREAK AT ONE POINT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE DOCTOR STATED THAT HE HAS NOTICED THIS LATELY WITH THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 23524372 ↗
• MalfunctionNov 11, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DOCTOR STATED WHEN HE SHAPED THE WIRE THE TIP FEELS LIKE IT BREAKS OR WAS BROKEN. THE TYPE OF PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE FIELD CLINICAL SPECIALIST (FCS) WAS PRESENT FOR THE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE DOCTOR COMMENTED THAT THE WIRE TIP SEEMED BROKEN WHEN HE WENT TO SHAPE IT. THERE WAS NO HARM CAUSED TO THE PATIENT. THE TIP DID NOT SEPARATE FROM THE WIRE HOWEVER IT DOES FEEL LIKE IT WAS BROKEN. WHEN WAS SHAPED THE WIRE INSTEAD OF THE TIP REPLICATING A NICE CURVE, IT SEEMED TO KINK OR BREAK AT ONE POINT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE DOCTOR STATED THAT HE HAS NOTICED THIS LATELY WITH THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 23524370 ↗
• InjuryNov 11, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DOCTOR STATED WHEN HE SHAPED THE WIRE THE TIP FEELS LIKE IT BREAKS OR WAS BROKEN. THE TYPE OF PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE FIELD CLINICAL SPECIALIST (FCS) WAS PRESENT FOR THE PROCEDURE ON (B)(6). DURING THE PROCEDURE, THE DOCTOR COMMENTED THAT THE WIRE TIP SEEMED BROKEN WHEN HE WENT TO SHAPE IT. THERE WAS NO HARM CAUSED TO THE PATIENT. THE TIP DID NOT SEPARATE FROM THE WIRE HOWEVER IT DOES FEEL LIKE IT WAS BROKEN. WHEN WAS SHAPED THE WIRE INSTEAD OF THE TIP REPLICATING A NICE CURVE, IT SEEMED TO KINK OR BREAK AT ONE POINT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE DOCTOR STATED THAT HE HAS NOTICED THIS LATELY WITH THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 23524149 ↗
• MalfunctionNov 11, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DOCTOR STATED WHEN HE SHAPED THE WIRE THE TIP FEELS LIKE IT BREAKS OR WAS BROKEN. THE TYPE OF PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE FIELD CLINICAL SPECIALIST (FCS) WAS PRESENT FOR THE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE DOCTOR COMMENTED THAT THE WIRE TIP SEEMED BROKEN WHEN HE WENT TO SHAPE IT. THERE WAS NO HARM CAUSED TO THE PATIENT. THE TIP DID NOT SEPARATE FROM THE WIRE HOWEVER IT DOES FEEL LIKE IT WAS BROKEN. WHEN WAS SHAPED THE WIRE INSTEAD OF THE TIP REPLICATING A NICE CURVE, IT SEEMED TO KINK OR BREAK AT ONE POINT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE DOCTOR STATED THAT HE HAS NOTICED THIS LATELY WITH THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 23524147 ↗
• InjuryOct 22, 2025Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED THAT "THE DATE OF EVENT IS AUGUST 2025. THE WIRE FRACTURED IN THE CORONARY ARTERY. ATTEMPTED REMOVAL OF WIRE, APPROXIMATELY 10 MM OF WIRE LEFT IN VESSEL. PATIENT HAD NO CHEST PAIN AND HEMODYNAMICALLY STABLE WHEN PROCEDURE WAS COMPLETED. THE PROCEDURE WAS A LEFT HEART CATHETERIZATION." ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2025: ALL KNOWN INFORMATION WAS REPORTED TO MEDSUN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23359033 ↗
• InjuryOct 22, 2025Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED THAT "THE DATE OF EVENT IS AUGUST 2025. THE WIRE FRACTURED IN THE CORONARY ARTERY. ATTEMPTED REMOVAL OF WIRE, APPROXIMATELY 10 MM OF WIRE LEFT IN VESSEL. PATIENT HAD NO CHEST PAIN AND HEMODYNAMICALLY STABLE WHEN PROCEDURE WAS COMPLETED. THE PROCEDURE WAS A LEFT HEART CATHETERIZATION." ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2025: ALL KNOWN INFORMATION WAS REPORTED TO MEDSUN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23357754 ↗
• InjurySep 16, 2025Fracture; Material Frayed; Fracture; Material Frayed

  TERUMO MEDICAL RECEIVED A REPORT INVOLVING A WIRE MALFUNCTION DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE RTNS WIRE WAS POSITIONED IN A BRANCH VESSEL. UPON REMOVAL, THE WIRE BEGAN TO FRAY, AND A WIRE FRACTURE OCCURRED. THE WIRE WAS NOT TRAPPED BEHIND A STENT OR ANY OTHER OBSTRUCTION. MOST OF THE FRACTURED WIRE WAS SUCCESSFULLY SNARED AND REMOVED. THE EVENT OCCURRED INTRA-OPERATIVELY. THE PATIENT REMAINED STABLE AND RECOVERED FROM THE PROCEDURE. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 21 AUG 2025: THE ISSUE BECAME APPARENT UNDER FLUOROSCOPY WHILE ATTEMPTING TO RETRACT THE WIRE. NO TESTING WAS PERFORMED. A PORTION OF THE WIRE REMAINS IN THE PATIENT'S LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO FURTHER ATTEMPTS WILL BE MADE TO RETRIEVE THE REMAINING WIRE. THE SAMPLE IS CONTAMINATED WITH BLOOD AND BODY FLUID BUT IS NOT CONTAMINATED WITH INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23069843 ↗

Other Terumo Corporation products

• CAPIOXFX12 models · 328 reports
• GLIDEWIRE30 models · 194 reports
• CAPIOXRX9 models · 162 reports
• GLIDEWIRE ADVANTAGE5 models · 79 reports
• GLIDECATH9 models · 57 reports
• R2P MISAGO13 models · 54 reports
• NAVICROSS11 models · 49 reports
• GUIDE WIRE M6 models · 37 reports