Dorado® DR80108Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 10 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 00801741059575), received between Jan 13, 2017 and Dec 1, 2023 — 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
- Leak/Splash2
- Detachment of Device or Device Component1
- Material Frayed1
- Peeled/Delaminated1
- Retraction Problem1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2023Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE TO TREAT A STENOSIS IN THE BRACHIOCEPHALIC VEIN, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT THE JUNCTION OF THE CATHETER TO FIBER PORTION OF THE BALLOON AND LEAKED CONTRAST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18244644 ↗MalfunctionJun 8, 2018Break; Material Frayed; Peeled/Delaminated; Break; Material Frayed; Peeled/Delaminated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN AN UPPER ARM AV FISTULA, AN ALLEGED PIN HOLE RUPTURE OCCURRED IN THE PTA BALLOON PRIOR TO REACHING NOMINAL PRESSURE. THE BALLOON WAS REMOVED IN ITS ENTIRETY THROUGH THE SHEATH WITHOUT DIFFICULTY. THERE WAS NO REPORTED DETACHMENT OF BALLOON MATERIAL NOR ANY VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7582298 ↗MalfunctionSep 19, 2017Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY GOT STUCK INSIDE THE SHEATH AND DETACHED FROM THE CATHETER AS IT WAS BEING WITHDRAWN THROUGH THE SHEATH. REPORTEDLY, THE HEALTH CARE PROVIDER REMOVED THE BALLOON AND SHEATH AS A SINGLE UNIT. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6877489 ↗MalfunctionJan 13, 2017Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A BIG AND TORTUOUS FISTULA AT THE DISTAL CEPHALIC VEIN, CONTRAST WAS ALLEGEDLY LEAKING AT THE DISTAL END OF THE PTA BALLOON UPON THE FIRST INFLATION. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE SHEATH. REPORTEDLY, ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6252090 ↗
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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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