Dorado® DR8098Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741059476), received between Apr 14, 2017 and Dec 9, 2023 — 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.

• MalfunctionDec 9, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT COME OUT OF SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON AND THE SHEATH WAS REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298144 ↗
• MalfunctionNov 29, 2023Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON HAD ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE SHEATH AND THE BALLOON WERE REMOVED AS ONE UNIT AND THE TIP OF THE SHEATH WAS APPEARED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225466 ↗
• MalfunctionJan 16, 2020Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL DR8098 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED INFLATION ISSUE, BREAK, AND A LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597967 ↗
• MalfunctionDec 18, 2017Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUBCLAVIAN VEIN, RESISTANCE WAS ALLEGEDLY FELT WHEN THE BALLOON WAS RETRACTED TO THE SHEATH AND SUBSEQUENTLY DETACHED FROM THE CATHETER SHAFT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126345 ↗
• MalfunctionSep 13, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY DETACHED FROM THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6862542 ↗
• MalfunctionMay 2, 2017Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A BRACHIOCEPHALIC FISTULA, THE HEALTH CARE PROVIDER (HCP) ALLEGEDLY HAD DIFFICULTY REMOVING THE PTA BALLOON THROUGH THE 6FR SHEATH AFTER THE SECOND INFLATION. REPORTEDLY, THE SHEATH AND BALLOON WERE REMOVED AS A SINGLE UNIT. WHILE MAINTAINING THE WIRE ACCESS, THE HCP USED ANOTHER SHEATH AND BALLOON TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6538277 ↗
• MalfunctionApr 14, 2017Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A ARTERIAL VENOUS GRAFT, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY RETRACTING THROUGH THE 6FR SHEATH. DURING RETRACTION THE BALLOON BROKE INSIDE THE SHEATH AND THE HEALTH CARE PROVIDER REMOVED BOTH BALLOON AND SHEATH TOGETHER AS ONE UNIT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6495635 ↗