Dorado® DR80102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741059490), received between Mar 24, 2017 and Jul 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL DR80102 PTA BALLOON DILATATION CATHETER ALLEGEDLY LEAKED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6) YEARS OLD. WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286673 ↗
• MalfunctionMar 24, 2017Break; Deflation Problem; Retraction Problem; Break; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTIES DEFLATING. UPON REMOVAL FROM THE PATIENT, THE BALLOON ALLEGEDLY GOT STUCK INSIDE THE 6FR SHEATH. THE PARTIALLY INFLATED PTA BALLOON AND INTRODUCER SHEATH WERE REMOVED AS ONE UNIT OVER THE GUIDEWIRE AND ANOTHER BALLOON AND SHEATH WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6434419 ↗