PROGREAT MC*PV2815YRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350718426), received between May 31, 2022 and Feb 13, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Separation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 31, 2022Break; Migration; Break; Migration

  THE USER FACILITY REPORTED THAT THE RADIOPAQUE MARKER ON THE PROGREAT DEVICE INVOLVED BROKE OFF AND MIGRATED. THE BROKEN PIECE GOT STUCK IN A STENOSIS AND THE DOCTOR WAS UNABLE TO RETRIEVE IT. THE PATIENT WAS OKAY. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS POSITIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14547610 ↗