PROGREAT MC*PE24131YBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04987350729286), received between Jul 25, 2022 and Jul 28, 2026 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, 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 ↗
• 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 ↗
• MalfunctionJul 25, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DURING A LEFT INTERNAL ILIAC ARTERY EMBOLIZATION PROCEDURE. A PROGREAT COAXIAL 2.8FR X 130CM WAS ADVANCED THROUGH 4FR X 100CM ANGLED GLIDECATH. DUE TO TORTUOSITY AND COMPLEX ANATOMY ACCESS TOOK A WHILE. COAXIAL GLIDEWIRE GT WAS SWITCHED OUT FOR AN .018" X 300CM GLIDE WIRE ADVANTAGE FOR SUPPORT. PHYSICIAN NOTED THAT 2.8FR PROGREAT WAS FEELING TIGHT AND GETTING STUCK IN GLIDECATH. 2.8FR PROGREAT WAS SWITCHED OUT FOR A 2.4FR X 130CM PROGREAT. THE CATHETER WAS FLUSHED AND PREPPED AND A GWA WIRE WAS WIPED. HOWEVER, THE PROGREAT GOT STUCK ON THE WIRE. THE PROGREAT REMOVED AND WIRE WIPED AND PROGREAT FLUSHED. HOWEVER, 2.4FR PROGREAT GOT STUCK AGAIN. THIS TIME SIGNIFICANT FORCE WAS REQUIRED TO REMOVE THE PROGREAT AND DURING THAT TIME THE PROGREAT SEPARATED AT DISTAL SECTION OF MICROCATHETER WHERE COLOR CHANGES TO GREY. WIRE ACCESS WAS LOST AND A NEW GWA .018" X 300CM WIRE OPENED AND USED. PROCEDURE CONTINUED BUT HAD TO BE STOPPED AS COMPLEX ANATOMY AND FLUORO TIME AND PATIENT RADIATION EXPOSURE WERE BECOMING A CONCERN. PATIENT WILL NEED TO BE BROUGHT BACK FOR AMPLATZER PLUG IN DISTAL VESSEL. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15095353 ↗