Dorado® DR8088Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741059322), received between Apr 15, 2019 and Oct 3, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BURST AT A PRESSURE BETWEEN THE NOMINAL AND BURST PRESSURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858847 ↗
• MalfunctionJul 16, 2020Leak/Splash; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8088 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE (B)(6) YEARS OLD MALE PATIENT. WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286923 ↗
• MalfunctionJul 16, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8088 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE COMPONENT AND BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10286807 ↗
• MalfunctionApr 20, 2020Break; Leak/Splash; Break; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8088 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED LEAK/SPLASH AND BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS FEMALE, AND THE WEIGHT IS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979591 ↗
• MalfunctionApr 15, 2020Break; Retraction Problem; Break; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8088 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEMS AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) YEAR OLD MALE. WEIGHT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965272 ↗
• MalfunctionApr 15, 2019Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL DR8088 DORADO PTA BALLOON DILATATION CATHETER HAD ISSUES RETRACTING. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. IN BOTH EVENTS, THE WEIGHT, AGE, AND SEX OF EACH PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516204 ↗