Dorado® DR8076Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 7 mm x 60 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741059025), received between Jul 22, 2019 and Sep 12, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Inflation Problem2
- Material Rupture2
- Break1
- Detachment of Device or Device Component1
- Device Damaged Prior to Use1
- Leak/Splash1
- Packaging Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS ALLEGEDLY SEPARATING FROM THE BALLOON. IT WAS FURTHER REPORTED THAT IT WOULD NOT INFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036583 ↗MalfunctionOct 17, 2024Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Packaging Problem; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PACKAGING WAS ALLEGEDLY CRUSHED. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS DAMAGED. FURTHERMORE, THE BOX WAS ALLEGEDLY TORN ON SIDE AND BENT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469631 ↗MalfunctionSep 9, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE; WHILE TRYING TO INFLATE THE BALLOON, THE PTA BALLOON WAS ALLEGEDLY FOUND TO HAVE A PINHOLE TEAR. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20167308 ↗MalfunctionAug 4, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN ILIAC, THE PTA BALLOON WAS FULLY INFLATED, AND PRESSURE DROPPED TO 4 ATM. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY WOULD NOT INFLATE HIGHER. IT WAS ALSO REPORTED THAT THE PTA BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17457166 ↗MalfunctionJul 22, 2019Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8076 PTA BALLOON DILATATION CATHETER WAS ALLEGEDLY DIFFICULT TO INFLATE AND ALLEGEDLY LEAKED AND BROKE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED TO BE A (B)(6) YEAR-OLD MALE, WEIGHING (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8811770 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page