Dorado® DR8078Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 7 mm x 80 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 00801741059063), received between Jun 19, 2017 and Dec 5, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Device Damaged Prior to Use1
- Leak/Splash1
- Material Deformation1
- Material Rupture1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON FOR AVG THROMBOLYSIS. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY HAD PINHONE RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724698 ↗MalfunctionSep 18, 2024Break; Device Damaged Prior to Use; Material Deformation; Break; Device Damaged Prior to Use; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY NOTED TO BE DAMAGED UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20243828 ↗MalfunctionMar 1, 2021Break; Break
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11395205 ↗MalfunctionJun 19, 2017Break; Retraction Problem; Break; Retraction Problem
IT WAS REPORTED THAT DURING A FISTULAGRAM THE PTA BALLOON ALLEGEDLY WOULD NOT COME OUT OF THE 6FR SHEATH AFTER COMPLETING NINE INFLATIONS. REPORTEDLY, THE BALLOON BEGAN TO ACCORDION AS IT WAS BEING WITHDRAWN THROUGH THE SHEATH. THE SHEATH AND BALLOON WERE REMOVED AS A SINGLE UNIT. THE HEALTH CARE PROVIDER USED A NEW SHEATH AND INJECTED CONTRAST IN THE VESSEL AND CONFIRMED THAT NO FURTHER TREATMENT WAS NEEDED. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6652513 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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