Dorado® DR135510Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741058592), received between Apr 16, 2019 and Apr 5, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED DURING WITHDRAWAL THROUGH A 6F INTRODUCER SHEAT. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612477 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR135510 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS MALE; HOWEVER, THE PATIENTS AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965460 ↗
• MalfunctionJan 16, 2020Material Frayed; Device-Device Incompatibility; Material Deformation; Material Frayed; Device-Device Incompatibility; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL DR135510 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEVICE-DEVICE INCOMPATIBILITY, MATERIAL FRAYED AND MATERIAL DEFORMATION. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE DEVICE WAS USED IN A (B)(6) YEAR-OLD FEMALE PATIENT, (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596864 ↗
• MalfunctionJul 22, 2019Break; Break

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR135510 PTA BALLOON DILATATION CATHETER ALLEGEDLY BROKE AFTER ONE INFLATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT WAS A 98 YEAR OLD FEMALE, WEIGHING 50 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812360 ↗
• MalfunctionApr 16, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL DR135510 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED. THESE REPORT WAS RECEIVED FROM VARIOUS SOURCE. OF THE ONE EVENT, DID INVOLVED PATIENTS WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519702 ↗