Dorado® DR8044Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 4 mm x 40 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
- 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 00801741058301), received between Jun 20, 2017 and Jun 21, 2024 — 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
- Leak/Splash3
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT FIRST EXTENSION AT 11 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19584124 ↗MalfunctionNov 15, 2022Leak/Splash; Device Dislodged or Dislocated; Leak/Splash; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CONNECTION PART NEAR THE HUB WAS NOT CONNECTED COMPLETELY. IT WAS FURTHER REPORTED THAT THE PRESSURE LEAKAGE WAS CONFIRMED FROM SAME PART. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15795644 ↗MalfunctionOct 20, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE THROUGH SUPERFICIAL FEMORAL ARTERY VIA CFA/POPLITEAL, THE BALLOON ALLEGEDLY HAD LEAKAGE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12662812 ↗MalfunctionMar 8, 2018Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT DURING TREATMENT FOR A SHUNT, THE PTA BALLOON ALLEGEDLY LEAKED ON THE FIRST INFLATION. REPORTEDLY, THERE WAS NO ISSUE RETRACTING THE BALLOON THROUGH THE SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7325629 ↗MalfunctionSep 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE ANGIOPLASTY PROCEDURE FOR STENOSIS NEAR AN ANASTOMOTIC SITE, THE HEALTH CARE PROVIDER INFLATED THE BALLOON TO 20 ATM WITH AN INFLATION DEVICE AND TRIED TO KEEP THE BALLOON INFLATED AT THAT PRESSURE FOR 3 MINUTES. REPORTEDLY, AFTER KEEPING THE PRESSURE AT 20 ATM FOR 5 SECONDS THE INFLATION HUB ALLEGEDLY CAME OFF THE CATHETER AND THE CONTRAST MEDIUM SPATTERED. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6873013 ↗MalfunctionJun 20, 2017Break; Break
IT WAS REPORTED THAT DURING THE FIRST INFLATION, THE PTA BALLOON CATHETER ALLEGEDLY WOULD NOT HOLD PRESSURE BEYOND 24 ATM. THE BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. UPON REMOVAL OF THE BALLOON CATHETER, THE HEALTH CARE PROVIDER ALLEGEDLY IDENTIFIED A BREAK AT THE BALLOON-CATHETER BUTT JOINT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6655754 ↗
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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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