Dorado® DR13554Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 5 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741058516), received between Nov 28, 2016 and May 19, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
Device problems
- Leak/Splash2
- Break1
- Device Dislodged or Dislocated1
- Material Rupture1
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE INFLATION DEVICE ALLEGEDLY LEAKED AT THE POINT BY THE GUIDEWIRE LIGHT DURING INFLATION. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11846866 ↗MalfunctionJul 17, 2020Leak/Splash; Material Rupture; Material Split, Cut or Torn; Leak/Splash; Material Rupture; Material Split, Cut or Torn
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR13554 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 AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10291074 ↗MalfunctionNov 28, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING THE PROCEDURE, THE MARKER BANDS OF THE PTA BALLOON CATHETER ALLEGEDLY APPEARED TOO CLOSE TO EACH OTHER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6129731 ↗
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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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