Dorado® DR13584Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741059278), received between Jan 16, 2020 and Jan 22, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Break; Difficult to Open or Remove Packaging Material; Material Deformation; Break; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PLASTIC COVER ALLEGEDLY WOULD NOT COME OFF THE BALLOON. IT WAS FURTHER REPORTED THAT THE CATHETER WAS DEFORMED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207472 ↗
• MalfunctionJan 16, 2020Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR13584 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION, BREAK, AND DEVICE-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MATERIAL DEFORMATION, BREAK, AND DEVICE-DEVICE INCOMPATIBILITY, ONE INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) YEARS OLD MALE AND WEIGHED (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596996 ↗