Dorado® DR135610Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 6 mm x 100 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741058851), received between Jul 19, 2019 and Jan 5, 2025 — classified as 6 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
- Detachment of Device or Device Component2
- Leak/Splash1
- Material Deformation1
- Material Frayed1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY BROKE OFF COMPLETELY INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21076153 ↗MalfunctionDec 7, 2020Break; Material Frayed; Material Deformation; Break; Material Frayed; Material Deformation
IT WAS REPORTED THAT PRIOR TO A PTA PROCEDURE, THE BALLOON WAS ALLEGEDLY FOUND TO BE FRAYED AFTER REMOVING THE PROTECTIVE SLEEVE OFF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10957327 ↗MalfunctionJul 16, 2020Break; Leak/Splash; Break; Leak/Splash
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR135610 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK AND LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO REPORTED PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE, WEIGHING (B)(6) LBS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10286708 ↗MalfunctionApr 20, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR135610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A FEMALE; WEIGHT AND AGE WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9979590 ↗MalfunctionJul 22, 2019Break; Break
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR135610. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE TWO EVENTS, BOTH INVOLVED PATIENTS WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR BOTH PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8812450 ↗MalfunctionJul 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR135610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT'S WEIGHT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8809127 ↗
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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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