PROGREAT MC*PE24151YVRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350735287), received between Feb 10, 2026 and Feb 10, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗