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PROGREAT MC*PB2411YRecalls & reported problems

Terumo Corporation · PROGREAT Microcatheter System · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987350781192), received between Oct 12, 2020 and Oct 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 12, 2020Break; Break

    THIS REPORT HAS BEEN DEEMED REPORTABLE BASED UPON EVALUATION OF THE ACTUAL SAMPLE. THE USER FACILITY REPORTED THAT THE INVOLVED PROGREAT BROKE IN HALF WHILE REMOVING IT FROM THE HOOP. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS REPORTED TO BE DISCHARGED- NORMAL. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 11AUG2020. THE PROCEDURE BEING PERFORMED WAS A PAE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROGREAT. THE WHOLE PROGREAT WAS BELIEVED TO BE ACCOUNTED FOR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10661364 ↗

Other Catheter, continuous flush devices

All Catheter, continuous flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.