Dorado® DR8086Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741059292), received between Aug 23, 2017 and Mar 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, WHILE FLUSHING THE BALLOON ALLEGEDLY CAME OFF OF THE SHAFT. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660488 ↗
• MalfunctionAug 23, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE LEFT ARM FISTULA, THE HUB OF THE PTA BALLOON CATHETER WAS ALLEGEDLY FOUND TO BE LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354205 ↗
• MalfunctionJan 16, 2020Break; Inflation Problem; Break; Inflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8086, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED A BREAK AND AN INFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A (B)(6) YEAR OLD MALE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597450 ↗
• MalfunctionOct 24, 2018Deflation Problem; Retraction Problem; Detachment of Device or Device Component; Deflation Problem; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE AND COULD NOT BE REMOVED FROM THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON DETACHED WHILE RETRACTING. THE DETACHED MATERIAL WAS REMOVED WITH THE SHEATH, AS ONE UNIT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8002752 ↗
• MalfunctionAug 23, 2018Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN AN ARM FISTULA, THE PTA BALLOON HAD DIFFICULTY RETRACTION THROUGH THE SHEATH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809820 ↗
• MalfunctionSep 8, 2017Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AN ALLEGED LEAK WAS FOUND BETWEEN THE CATHETER SHAFT AND THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6854108 ↗
• MalfunctionAug 23, 2017Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AN ALLEGED LEAK WAS FOUND BETWEEN THE CATHETER SHAFT AND THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6814337 ↗