PROGREAT MC*PE28131YBRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04987350771810), received between Nov 22, 2016 and Sep 13, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  THE PATIENT UNDERWENT A UTERINE ARTERY EMBOLIZATION VIA FEMORAL ACCESS. A CATHETER WAS INSERTED INTO THE PATIENT'S HYPOGASTRIC ARTERY, AND THE 2.8FR X 130CM PROGREAT MICROCATHETER WAS USED TO SELECT THE ARTERY. THE ORIGINAL WIRE FROM THE MICROCATHETER WAS REPLACED WITH A .016 FATHOM WIRE. THIS ASSEMBLY WAS THREADED THROUGH THE TOUHY INCLUDED WITH THE PROGREAT AND INTRODUCED INTO THE PATIENT. THE FELLOW REPORTED NO ISSUES IN ADVANCING THE MICROCATHETER THROUGH THE TOUHY, AND IT DID NOT APPEAR TO KINK OR CATCH DURING INSERTION. HOWEVER, WHEN THE MICROCATHETER WAS ADVANCED OVER THE WIRE INTO THE BODY, THE WIRE WAS OBSERVED PROTRUDING FROM THE SIDE RATHER THAN THE END, SUGGESTING A SIDEHOLE. ATTEMPTS TO RETRACT THE MICROCATHETER WITHIN THE BASE CATHETER LED TO THE SEPARATION OF THE PROGREAT'S TIP, WHICH DID NOT RETRACT WITH THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE WIRE, MICROCATHETER, AND CATHETER TOGETHER, AND THE PROGREAT'S TIP WAS RETRIEVED WITH THEM. A NEW MICROCATHETER AND WIRE WERE USED TO CONTINUE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT'S CONDITION REMAINING STABLE AND NO REMNANTS OF THE DAMAGED PROGREAT LEFT INSIDE. ADDITIONAL INFORMATION WAS REC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215349 ↗
• MalfunctionMay 17, 2023Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS FINISHING A THORACIC DUCT EMBOLIZATION DIRECT PERCUTANEOUS APPROACH VIA COOK 22G CHIBA NEEDLE. UPON REMOVING 2.8 THE PROGREAT WITH V18 WIRE IN IT, THE WIRE GOT STUCK INSIDE THE MICROCATHETER AND CHIBA NEEDLE. THE DOCTOR PULLED EXTREMELY HARD, AND IT WAS ALL REMOVED. ALL THE ITEMS CAME OUT. THE PATIENT WAS FINE. THERE WAS NO PATIENT INJURY OR INTERVENTION NEEDED. THE PATIENT WAS RECOVERING FROM THE THORACIC DUCT EMBOLIZATION. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946736 ↗
• InjuryAug 26, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE RADIFOCUS CATHETER BROKE APART IN THE EXTERNAL CAROTID ARTERY. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 05AUG2019. THE PROCEDURE WAS A VISCERAL PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 8931084 ↗
• InjuryAug 26, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE RADIFOCUS CATHETER BROKE APART IN THE EXTERNAL CAROTID ARTERY. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 05AUG2019. THE PROCEDURE WAS A VISCERAL PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 8931083 ↗
• InjuryJun 6, 2018Material Separation; Material Separation

  THE USER FACILITY REPORTED A PIECE OF THE PROGREAT (2.8 130 CM) CATHETER BROKE OFF IN THE PATIENT'S BODY. THE PHYSICIAN WAS ABLE SNARE THE PIECE OUT, AND THERE WERE NO PIECES REMAINING IN THE PATIENT. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS DOING FINE. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 29, 2018. THERE WAS NO BLOOD LOSS DUE TO THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7575249 ↗
• InjuryAug 24, 2017Break; Break

  THE USER FACILITY REPORTED THAT THE TIP WITH MARKER CAME OFF DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT CONDITION IS FINE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6816116 ↗
• MalfunctionNov 22, 2016Break; Break

  THE USER FACILITY REPORTED DEVICE SEPARATION DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: 76MM OF THE PROXIMAL END OF THE CATHETER BECAME SEPARATED; THE ATTENDING TECH REPORTED THAT THE SEPARATION OF THE CATHETER OCCURRED OUTSIDE OF THE PATIENT'S BODY DURING REMOVAL; THE PROCEDURE WAS COMPLETED; AND THE PATIENT'S CONDITION WAS REPORTED AS GOOD WITH NO IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6122508 ↗