PROGREAT MC*PB2413YRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04987350781215), received between Jul 14, 2020 and Dec 29, 2025 — classified as 4 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 25, 2020Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED ON 21OCT2020. THE USER INJECTED THE EMBOLUS VIA HAND INJECTIONS. THE USER FLUSHED THE CATHETER WHEN THE EMBOLUS MATERIAL BECAME STUCK IN THE CATHETER WITH A HAND INJECTION. THERE WAS NO USE OF A POWER INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10585521 ↗
• InjuryAug 25, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED PROGREAT BROKE IN THE PATIENT. THE PROCEDURE OUTCOME AND PATIENT CONDITION WERE NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 28JUL2020. THE MICROCATHETER WAS INSERTED INTO PATIENT. WHEN MANIPULATING, IT WAS SEEN ON FLUOROSCOPY THAT A FRAGMENT WAS STUCK IN THE PATIENT. IT WAS REMOVED VIA A SNARE. THE PATIENT RECOVERED WITHOUT FURTHER COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. BASED ON THE EVALUATION RESULTS OF THE ACTUAL SAMPLE ON AUGUST 5, 2020, THE TYPE OF EVENT WAS UPDATED TO SERIOUS INJURY.

  Patient problems: No Code Available

  MAUDE report 10447581 ↗
• InjuryJul 14, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED PROGREAT BROKE IN THE PATIENT. THE PROCEDURE OUTCOME AND PATIENT CONDITION WERE NOT REPORTED.

  Patient problems: No Code Available; No Information

  MAUDE report 10270048 ↗