Dorado® DR80810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741059360), received between Apr 26, 2017 and Sep 1, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY IN REMOVING FROM THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON WAS PULLED ALONG WITH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408114 ↗
• MalfunctionJul 24, 2019Break; Retraction Problem; Break; Retraction Problem

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR80810 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823029 ↗
• MalfunctionApr 18, 2018Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PTA BALLOON CATHETER WOULD NOT FULLY WITHDRAW THROUGH THE SHEATH. THE BALLOON BECOME STUCK IN THE SHEATH AND NECESSITATED REMOVAL OF BOTH THE BALLOON AND SHEATH TOGETHER. IT WAS FURTHER ALLEGED THAT THE BALLOON DETACHED UPON REMOVING THE BALLOON AND SHEATH. REPORTEDLY, THE HEALTH CARE PROVIDER USED A LARGER BALLOON CATHETER AND SHEATH TO CONTINUE THE PROCEDURE. THE PATIENT WAS REPORTED AS DOING FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442068 ↗
• MalfunctionApr 26, 2017Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING A FISTULA ANGIOPLASTY PROCEDURE, THE BALLOON WAS IDENTIFIED WITH AN ALLEGED PINHOLE RUPTURE AS IT WOULD NOT HOLD PRESSURE AT 16 ATM DURING THE FIRST INFLATION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED WITHOUT INCIDENT AND WAS EXCHANGE OVER THE WIRE FOR ANOTHER, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6523540 ↗