PROGREAT MC*PC2015YRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350727381), received between May 28, 2019 and May 31, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 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.

• 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 14547612 ↗
• MalfunctionJan 20, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PHYSICIAN USED A .016 FATHOM WIRE WITH THE MICROCATHETER EVEN AFTER BEING ADVISED BY THE TERUMO FIELD CLINICAL SPECIALIST THAT SOMETIMES THE JACKET ON THAT WIRE IS BIGGER THAN .016 AND CAN CAUSE THE WIRE TO GET STUCK. THE PHYSICIAN WAS JUST ABOUT WHERE HE WANTED TO BE WITH THE MICROCATHETER HOWEVER WANTED A COUPLE MORE CENTIMETERS SO HE REMOVED THE .016 FATHOM WIRE AND INSERTED A .014 NITREX WIRE SO HE COULD REMOVE THE MICROCATHETER AND TAKE OFF THE TOUHY TO GAIN THE FEW CENTIMETERS HE NEEDED. WHEN HE DID THAT, HE NOTICED THE TIP OF THE MICROCATHETER WAS DAMAGED AND COULD NOT BE PUT BACK ON THE WIRE TO REINSERT. AT THAT POINT HE WAS GIVEN ANOTHER PROGREAT ALPHA 2.0 AND THEY WERE ABLE TO COMPLETE THE CASE WITHOUT ISSUE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON-09-DEC 2021: THE PROCEDURE FOR THE PATIENT WAS A PROSTATE ARTERY EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310784 ↗
• MalfunctionMay 28, 2019Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO DO A TYPE 2 ENDOLEAK EMBOLIZATION. HE WAS ABLE TO GET THE PROGREAT IN PLACE AND DECIDED TO USE ONYX TO EMBOLIZE. UPON ATTEMPTING TO USE THE ONYX, HE FELT A LOT OF RESISTANCE AND CONTINUED TO PUSH. THE ONYX COULD NOT BE VISUALIZED COMING OUT OF THE CATHETER; HOWEVER, IT COULD BE SEEN COMING OUT THE SIDE IN THE LARGE COLIC. THE LARGE COLIC WAS NONE TARGETED EMBOLIZED. INTERVENTION WAS NOT GOING TO BE PURSUED AT THE TIME. THEY ARE GOING TO WATCH THE PATIENT AND SEE HOW HE RESPONDS. THE PHYSICIAN THOUGHT POST CASE, THAT HE DID NOT THINK IT WAS THE CATHETER AS MUCH AS IT WAS THE ONYX AND MAYBE AN ISSUE WITH THE PREPARATION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS NOT COMPLETED IN A TECHNICALLY SUCCESSFUL MANNER DUE TO THE KNOWN TARGET EMBO CASE WAS ABORTED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 9, 2019. THE PHYSICIAN HAD THE DISTAL TIP OF THE PROGREAT WHERE HE ACTUALLY WANTED TO TREAT; SEVERAL CENTIMETERS PROXIMAL TO THAT, THE ONYX STARTED COMING OUT THE SIDE OF THE PROGREAT AS THERE WAS A HOLE THERE. THE HOLE WAS CON

  Patient problems: No Code Available

  MAUDE report 8646200 ↗