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Dorado® DR8056Recalls & reported problems

Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 5 mm x 60 mm, 80 cm Catheter · Class 2

All models of Dorado (49)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741058523), received between May 22, 2017 and Dec 13, 2022 — classified as 4 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

Device problems

  • Break3
  • Material Rupture2
  • Detachment of Device or Device Component1
  • Difficult to Open or Remove Packaging Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 13, 2022Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

    IT WAS REPORTED THAT PRIOR TO A ANGIOPLASTY PROCEDURE THE BALLOON COVER ALLEGEDLY DIFFICULT TO OPEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15970168 ↗
  • MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY SNAPPED IN HALF. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15724364 ↗
  • MalfunctionMay 22, 2017Break; Material Rupture; Break; Material Rupture

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC ARTERY THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM ON THE SECOND INFLATION ATTEMPT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6583518 ↗
  • MalfunctionMay 22, 2017Break; Material Rupture; Break; Material Rupture

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC ARTERY THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM ON THE FIRST INFLATION ATTEMPT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6583485 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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