PROGREATRecalls & reported problems across all models

We found 10 models of PROGREAT by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Jul 28, 2026 — classified as 21 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 PROGREAT problems

PROGREAT models

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

• PROGREAT MC*PE28131YB

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  7 reports
• PROGREAT MC*PB2413Y

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  5 reports
• PROGREAT MC*PE24131YB

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  4 reports
• PROGREAT MC*PV2815Y

  Catheter, continuous flush
  3 reports
• PROGREAT MC*PC2015Y

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  3 reports
• PROGREAT MC*PV2415Y

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 reports
• PROGREAT MC*PC2013Y

  Catheter, continuous flush
  2 reports
• PROGREAT MC*PE24151YV

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 reports
• PROGREAT MC*PB2813Y

  Catheter, continuous flush
  2 reports
• PROGREAT MC*PB2411Y

  Catheter, continuous flush
  1 report

Recent PROGREAT adverse event reports

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

• InjuryJul 28, 2026Break; Detachment of Device or Device Component

  Terumo Medical Corporation received the following information: It was reported that during a Visceral procedure, the progreat broke off inside the patient. On 10 July 2026: Additional information received: There was no blood loss. The event occurred during the Visceral procedure. The progreat fragment remains inside the patient.

  Patient problems: Foreign Body In Patient

  MAUDE report 50059905 ↗
• InjuryJul 28, 2026Break; Detachment of Device or Device Component

  Terumo received the following information: It was reported that during a Visceral procedure, the progreat broke off inside the patient.Additional information was received On 10 July 2026: There was no blood loss. The event occurred during the Visceral procedure. The progreat fragment remains inside the patient.

  Patient problems: Foreign Body In Patient

  MAUDE report 50059904 ↗
• InjuryFeb 10, 2026Break; Material Separation; Material Deformation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING THE SPLENIC ARTERY EMBOLIZATION, THE PROGREAT WAS INSERTED THROUGH GLIDECATH (INSIDE DESTINATION SHEATH) AND ADVANCED TO THE SPLENIC ARTERY. PER THE MEDICAL DOCTOR (MD), THE COIL 5X16 CX BECAME STUCK AND COULD NOT PUSH OR PULL COIL; THEREFORE, A COIL WAS DEPLOYED AND ATTEMPTED TO PUSH WITH 018 COMMAND WIRE. THE WIRE COULD NOT PUSH THE COIL, PER MD THE "PROGREAT BROKE". THE MD WAS ABLE TO RECOVER THE PROGREAT AND WAS ABLE TO RELEASE COIL PACK. COIL PACK LANDED IN THE INTENDED LOCATION, AND PROGREAT WAS REMOVED AND REPLACED. EMBOLIZATION WAS THEN COMPLETED, SUCCESSFUL, AND THE PATIENT WAS OK. LATER, THE MD STATED HE BELIEVED THE PROGREAT BECAME STUCK IN GLIDECATH DUE TO INADEQUATE FLUSHING, AND THE COIL BECAME STUCK FOR SIMILAR REASONS. ADDITIONAL INFORMATION WAS RECEIVED ON 31DEC2025: THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THEY WERE TAKEN BACK TO THE OPERATING ROOM (OR) FOR ANOTHER PROCEDURE THE FOLLOWING DAY, THOUGH IT WAS NOT THOUGHT THE PREVIOUS PROCEDURE WAS AT FAULT. THE TREATMENT WAS SUCCESSFUL; THE SPLENIC ARTERY WAS EMBOLIZED RESULTING IN REDUCTION OF BLEEDING FROM THE SPLEEN. NO ADDITION

  Patient problems: Foreign Body In Patient

  MAUDE report 24305898 ↗
• InjuryFeb 10, 2026Break; Material Separation; Material Deformation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING THE SPLENIC ARERTY EMBOLIZATION, THE PROGREAT WAS INSERTED THROUGH GLIDECATH (INSIDE DESTINATION SHEATH) AND ADVANCED TO THE SPLENIC ARTERY. PER THE MEDICAL DOCTOR (MD), THE COIL 5X16 CX BECAME STUCK AND COULD NOT PUSH OR PULL COIL; THEREFORE, A COIL WAS DEPLOYED AND ATTEMPTED TO PUSH WITH 018 COMMAND WIRE. THE WIRE COULD NOT PUSH THE COIL, PER MD THE "PROGREAT BROKE". THE MD WAS ABLE TO RECOVER THE PROGREAT AND WAS ABLE TO RELEASE COIL PACK. COIL PACK LANDED IN THE INTENDED LOCATION, AND PROGREAT WAS REMOVED AND REPLACED. EMBOLIZATION WAS THEN COMPLETED, SUCCESSFUL, AND THE PATIENT WAS OK. LATER, THE MD STATED HE BELIEVED THE PROGREAT BECAME STUCK IN GLIDECATH DUE TO INADEQUATE FLUSHING, AND THE COIL BECAME STUCK FOR SIMILAR REASONS. ADDITIONAL INFORMATION WAS RECEIVED ON 31DEC2025: THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THEY WERE TAKEN BACK TO THE OPERATING ROOM (OR) FOR ANOTHER PROCEDURE THE FOLLOWING DAY, THOUGH IT WAS NOT THOUGHT THE PREVIOUS PROCEDURE WAS AT FAULT. THE TREATMENT WAS SUCCESSFUL; THE SPLENIC ARTERY WAS EMBOLIZED RESULTING IN REDUCTION OF BLEEDING FROM THE SPLEEN. NO ADDITION

  Patient problems: Foreign Body In Patient

  MAUDE report 24305896 ↗
• MalfunctionJan 14, 2026Material Fragmentation; Physical Resistance/Sticking

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE SYSTEM WITH WIRE WAS VERY "STICKY" TO THE POINT THEY COULD BARELY REMOVE THE WIRE FROM THE CATHETER EVEN AFTER FLUSHING THROUGH BOTH PORTS. THE PROCEDURE WAS UNKNOWN, AND THE PATIENT WAS NOT AFFECTED. THE DEVICE WAS FLUSHED FROM BOTH PORTS' MULTIPLE TIMES, EVEN ALONGSIDE THE WIRE; HOWEVER, THEY COULD NOT GET THE WIRE OUT. THE WIRE WAS STUCK WITHIN THE CATHETER, AND THE WIRE ITSELF ENDED UP SHREDDING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068109 ↗
• InjuryDec 29, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: A MICROCATHETER WAS POSITIONED TO THE LOCATION OF EMBOLIZATION. THERE WAS ONE TORTUOUS PORTION WHERE SEVERAL COILS WERE NOT ABLE TO ADVANCE DESPITE THE PHYSICIANS ATTEMPTS TO FLUSH CATHETER AND REPOSITION. ONCE IT WAS DECIDED TO REMOVE THE MICROCATHETER FOR AN ALTERNATIVE THE CATHETER APPEARED DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 07DEC2025: ASHITAKA CONFIRMED THE TIP OF THE ACTUAL SAMPLE WAS SEVERED. ADDITIONAL INFORMATION WAS RECEIVED ON 08DEC2025: THERE WAS NO PATIENT HARM AND NO BROKEN FRAGMENTS INSIDE THE BODY. ADDITIONAL INFORMATION WAS RECEIVED ON 09DEC2025: THE PROGREAT WAS DELIVERED TO THE LOCATION WHERE THE PHYSICIANS WANT TO COIL. A COIL WAS DELIVERED SUCCESSFULLY, AND THE NEXT COIL DID NOT. IT WAS IMPOSSIBLE TO DETERMINE WHY, AND THE PHYSICIAN TRIED ANOTHER, HOWEVER IT ALSO WOULD DELIVER PAST THE TIP OF THE PROGREAT. WHEN THE PROGREAT WAS REMOVED, THE PHYSICIAN INDICATED THE TIP WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905669 ↗
• InjuryDec 29, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: A MICROCATHETER WAS POSITIONED TO THE LOCATION OF EMBOLIZATION. THERE WAS ONE TORTUOUS PORTION WHERE SEVERAL COILS WERE NOT ABLE TO ADVANCE DESPITE THE PHYSICIANS ATTEMPTS TO FLUSH CATHETER AND REPOSITION. ONCE IT WAS DECIDED TO REMOVE THE MICROCATHETER FOR AN ALTERNATIVE, THE CATHETER APPEARED DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 07DEC2025: ASHITAKA CONFIRMED THE TIP OF THE ACTUAL SAMPLE WAS SEVERED. ADDITIONAL INFORMATION WAS RECEIVED ON 08DEC2025: THERE WAS NO PATIENT HARM AND NO BROKEN FRAGMENTS INSIDE THE BODY. ADDITIONAL INFORMATION WAS RECEIVED ON 09DEC2025: THE PROGREAT WAS DELIVERED TO THE LOCATION WHERE THE PHYSICIANS WANT TO COIL. A COIL WAS DELIVERED SUCCESSFULLY, AND THE NEXT COIL DID NOT. IT WAS IMPOSSIBLE TO DETERMINE WHY, AND THE PHYSICIAN TRIED ANOTHER, HOWEVER IT ALSO WOULD DELIVER PAST THE TIP OF THE PROGREAT. WHEN THE PROGREAT WAS REMOVED, THE PHYSICIAN INDICATED THE TIP WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905667 ↗
• InjuryDec 12, 2024Break; Break

  TERUMO MEDICAL RECEIVED FDA MEDWATCH REPORT (B)(4). THE EVENT DESCRIPTION STATES: "WHILE REMOVING THE FATHOM WIRE THROUGH THE PRO GREAT MICROCATHETER, PART OF THE TIP OF THE WIRE (7-10CM) BROKE OFF IN THE ARTERY AND WAS UNABLE TO BE REMOVED DESPITE ATTEMPT VIA SNARE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: Y 90 RADIOEMBOLIZATION. SELECTIVE CATHETERIZATION CELIAC ARTERY FOR CELIAC ARTERY ANGIOGRAM. ORIGINAL INTENDED PROCEDURE: SUPERSELECTIVE CATHETERIZATION OF THE RIGHT HEPATIC ARTERY FOR RIGHT HEPATIC ARTERY ANGIOGRAM AND CONED BEAM CT. CONE BEAM DYNA CT WITH CATHETER POSITIONED IN HEPATIC ARTERIES WITH ADDITIONAL 3-D IMAGE POSTPROCESSING. TRANSARTERIAL DELIVERING Y90 SIRSHPHERES IN SUPERSELECTIVE RIGHT HEPATIC ARTERY. ULTRASOUND GUIDANCE FOR ARTERIAL ACCESS. LIMITED RIGHT COMMON FEMORAL ARTERY ANGIOGRAM AND CLOSURE DEVICE DEPLOYMENT FOR HEMOSTASIS".

  Patient problems: Foreign Body In Patient

  MAUDE report 20914171 ↗
• InjuryDec 12, 2024Break; Break

  TERUMO MEDICAL RECEIVED FDA MEDWATCH REPORT (B)(4). THE EVENT DESCRIPTION STATES: "WHILE REMOVING THE FATHOM WIRE THROUGH THE PRO GREAT MICROCATHETER, PART OF THE TIP OF THE WIRE (7-10CM) BROKE OFF IN THE ARTERY AND WAS UNABLE TO BE REMOVED DESPITE ATTEMPT VIA SNARE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: Y 90 RADIOEMBOLIZATION. SELECTIVE CATHETERIZATION CELIAC ARTERY FOR CELIAC ARTERY ANGIOGRAM. ORIGINAL INTENDED PROCEDURE: SUPERSELECTIVE CATHETERIZATION OF THE RIGHT HEPATIC ARTERY FOR RIGHT HEPATIC ARTERY ANGIOGRAM AND CONED BEAM CT. CONE BEAM DYNA CT WITH CATHETER POSITIONED IN HEPATIC ARTERIES WITH ADDITIONAL 3-D IMAGE POSTPROCESSING. TRANSARTERIAL DELIVERING Y90 SIRSHPHERES IN SUPERSELECTIVE RIGHT HEPATIC ARTERY. ULTRASOUND GUIDANCE FOR ARTERIAL ACCESS. LIMITED RIGHT COMMON FEMORAL ARTERY ANGIOGRAM AND CLOSURE DEVICE DEPLOYMENT FOR HEMOSTASIS."

  Patient problems: Foreign Body In Patient

  MAUDE report 20914014 ↗
• MalfunctionSep 13, 2024Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  THE PATIENT UNDERWENT A UTERINE ARTERY EMBOLIZATION VIA FEMORAL ACCESS. A CATHETER WAS INSERTED INTO THE PATIENT'S HYPOGASTRIC ARTERY, AND THE 2.8FR X 130CM PROGREAT MICROCATHETER WAS USED TO SELECT THE ARTERY. THE ORIGINAL WIRE FROM THE MICROCATHETER WAS REPLACED WITH A .016 FATHOM WIRE. THIS ASSEMBLY WAS THREADED THROUGH THE TOUHY INCLUDED WITH THE PROGREAT AND INTRODUCED INTO THE PATIENT. THE FELLOW REPORTED NO ISSUES IN ADVANCING THE MICROCATHETER THROUGH THE TOUHY, AND IT DID NOT APPEAR TO KINK OR CATCH DURING INSERTION. HOWEVER, WHEN THE MICROCATHETER WAS ADVANCED OVER THE WIRE INTO THE BODY, THE WIRE WAS OBSERVED PROTRUDING FROM THE SIDE RATHER THAN THE END, SUGGESTING A SIDEHOLE. ATTEMPTS TO RETRACT THE MICROCATHETER WITHIN THE BASE CATHETER LED TO THE SEPARATION OF THE PROGREAT'S TIP, WHICH DID NOT RETRACT WITH THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE WIRE, MICROCATHETER, AND CATHETER TOGETHER, AND THE PROGREAT'S TIP WAS RETRIEVED WITH THEM. A NEW MICROCATHETER AND WIRE WERE USED TO CONTINUE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT'S CONDITION REMAINING STABLE AND NO REMNANTS OF THE DAMAGED PROGREAT LEFT INSIDE. ADDITIONAL INFORMATION WAS REC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215349 ↗
• InjuryMar 5, 2024Stretched; Material Split, Cut or Torn; Physical Resistance/Sticking; Stretched; Material Split, Cut or Torn; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT A 6 FRENCH 90CM DESTINATION SHEATH WAS PLACED INTO THE LEFT BRACHIAL ARTERY AND EXTENDED INTO THE DISTAL AORTA. AN 035 RUBICON CATHETER WAS PLACED INTO A SMALL BRANCH OFF THE RIGHT INTERNAL ILIAC ARTERY AND A 018 THRUWAY WIRE WAS PLACED. THE 2.4 FRENCH PROGREAT WAS PLACED OVER THE WIRE WITH GREAT RESISTANCE FELT BY THE TECHNOLOGIST LOADING IT. IT WAS NOTED BY THE PHYSICIAN THAT THE TECHNOLOGIST WAS ACCIDENTALLY PINNING THE CATHETER TIP AND PUSHING THE BACK END OF THE CATHETER. AFTER THE TECHNOLOGIST REPOSITIONED THEIR HANDS, THE CATHETER WAS ABLE TO BE DELIVERED TO THE APPROPRIATE LOCATION OVER THE WIRE. THE WIRE WAS REMOVED, AND THE 018 10CM HYDOPACK COIL WAS INTRODUCED. ONE COIL WAS SUCCESSFULLY DELIVERED. THE SECOND COIL WAS DELIVERED; HOWEVER, INTENDED TO BE REPOSITIONED AND UPON REMOVAL, THE COIL BECAME DETACHED DUE TO RESISTANCE AND THE TAIL OF THE COIL WAS HANGING INTO THE COMMON ILIAC ARTERY IN AN UNWANTED LOCATION. THE PROGREAT WAS REMOVED; HOWEVER, IT WAS ELONGATED AND PARTIALLY TORN. THE PHYSICIAN DECIDED THAT NO ADDITIONAL INTERVENTION WAS NECESSARY AT THIS TIME. THE PROCEDURE PERFORMED WAS A TYPE 2 ENDOLEAK EMBOLIZATION OF RIGHT INTERNAL

  Patient problems: Insufficient Information

  MAUDE report 18838280 ↗
• InjuryMar 5, 2024Stretched; Material Split, Cut or Torn; Physical Resistance/Sticking; Stretched; Material Split, Cut or Torn; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT A 6 FRENCH 90CM DESTINATION SHEATH WAS PLACED INTO THE LEFT BRACHIAL ARTERY AND EXTENDED INTO THE DISTAL AORTA. AN 035 RUBICON CATHETER WAS PLACED INTO A SMALL BRANCH OFF THE RIGHT INTERNAL ILIAC ARTERY AND A 018 THRUWAY WIRE WAS PLACED. THE 2.4 FRENCH PROGREAT WAS PLACED OVER THE WIRE WITH GREAT RESISTANCE FELT BY THE TECHNOLOGIST LOADING IT. IT WAS NOTED BY THE PHYSICIAN THAT THE TECHNOLOGIST WAS ACCIDENTALLY PINNING THE CATHETER TIP AND PUSHING THE BACK END OF THE CATHETER. AFTER THE TECHNOLOGIST REPOSITIONED THEIR HANDS, THE CATHETER WAS ABLE TO BE DELIVERED TO THE APPROPRIATE LOCATION OVER THE WIRE. THE WIRE WAS REMOVED, AND THE 018 10CM HYDOPACK COIL WAS INTRODUCED. ONE COIL WAS SUCCESSFULLY DELIVERED. THE SECOND COIL WAS DELIVERED; HOWEVER, INTENDED TO BE REPOSITIONED AND UPON REMOVAL, THE COIL BECAME DETACHED DUE TO RESISTANCE AND THE TAIL OF THE COIL WAS HANGING INTO THE COMMON ILIAC ARTERY IN AN UNWANTED LOCATION. THE PROGREAT WAS REMOVED; HOWEVER, IT WAS ELONGATED AND PARTIALLY TORN. THE PHYSICIAN DECIDED THAT NO ADDITIONAL INTERVENTION WAS NECESSARY AT THIS TIME. THE PROCEDURE PERFORMED WAS A TYPE 2 ENDOLEAK EMBOLIZATION OF RIGHT INTERNAL

  Patient problems: Insufficient Information

  MAUDE report 18838156 ↗
• MalfunctionMay 17, 2023Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS FINISHING A THORACIC DUCT EMBOLIZATION DIRECT PERCUTANEOUS APPROACH VIA COOK 22G CHIBA NEEDLE. UPON REMOVING 2.8 THE PROGREAT WITH V18 WIRE IN IT, THE WIRE GOT STUCK INSIDE THE MICROCATHETER AND CHIBA NEEDLE. THE DOCTOR PULLED EXTREMELY HARD, AND IT WAS ALL REMOVED. ALL THE ITEMS CAME OUT. THE PATIENT WAS FINE. THERE WAS NO PATIENT INJURY OR INTERVENTION NEEDED. THE PATIENT WAS RECOVERING FROM THE THORACIC DUCT EMBOLIZATION. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946736 ↗
• InjuryFeb 13, 2023Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING EMBOLIZATION OF A TYPE II ENDOLEAK AND DURING ATTEMPTING SEVERAL WIRE AND CATHETER COMBINATIONS TO NAVIGATE THROUGH THE ARTERIAL ARCADE AND GAIN ACCESS TO THE INTERIOR MESENTERIC ARTERY, A TERUMO PROGREAT 2.4FR MICROCATHETER WITH A FATHOM WIRE WAS USED TO ATTEMPT CROSSING A TIGHT STENOSIS AT A HAIRPIN TURN. THE ATTEMPT WAS UNSUCCESSFUL TO ALLOW FOR SAFE EMBOLIZATION. UPON REMOVING THE PROGREAT MICROCATHETER AFTER BEING UNABLE TO CROSS THE LESION, IT WAS NOTED ON FLUOROSCOPY THAT A RADIOPAQUE 0.7MM PLATINUM/IRIDIUM MARKER THAT WAS PREVIOUSLY AT THE END OF THE CATHETER HAD BECOME DISLODGED INTO THE STENOSIS. AFTER REMOVAL OF THE MICROCATHETER AND WIRE FROM THE VETERAN, THE PROVIDER CONFIRMED THE TIP OF THE CATHETER AND WIRE WERE INTACT, HOWEVER, NOTED THE OUTSIDE RADIOPAQUE MARKER HAD BECOME DISLODGED. USING THE SAME WIRE AND CATHETER, WE SELECTED THE SUPERIOR MESENTERIC ARTERY (SMA) AND CONFIRMED CORRECT PLACEMENT WITH ANGIOGRAPHY. WE THEN ADVANCED OUR SHEATH INTO THE SUPERIOR MESENTERIC ARTERY (SMA) WITH THE DILATOR AND REPEATED THE ANGIOGRAM TO MARK THE ARC OF RIOLAN AND THE MEANDERING ARTERY BRANCH OFF THE SUPERIOR MESENTERIC ARTERY (SMA) FE

  Patient problems: Foreign Body In Patient

  MAUDE report 16364556 ↗
• InjuryJan 19, 2023Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 19 JAN 2023: THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE RADIOPAQUE MARKER WAS LEFT INSIDE THE OCCLUDED VESSEL. THERE IS NO ADDITIONAL INTERVENTION PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16209838 ↗

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