Dorado® DR135104Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 10 mm x 40 mm, 135 cm Catheter · Class 2
All models of Dorado (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741059568), received between Mar 8, 2021 and Mar 20, 2025 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Deflation Problem1
- Leak/Splash1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2025Break; Break
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN AND COULD NOT BE USED PROPERLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21651174 ↗MalfunctionNov 23, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT BRACHIAL ARTERY, THE PTA BALLOON ALLEGEDLY LEAKED AND A PINHOLE RUPTURE WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15850769 ↗InjuryMar 8, 2021Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY COULD NOT BE FULLY DEFLATED. IT WAS FURTHER REPORTED THAT A PERCUTANEOUS NEEDLE STICK WAS USED TO DEFLATE THE BALLOON. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11430963 ↗
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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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