Dorado® DR8042Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 4 mm x 20 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741058264), received between Dec 28, 2022 and Apr 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1 report).
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
- Material Rupture1
- Packaging Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2024Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PACKAGE OF THE PTA BALLOON WAS ALLEGEDLY NOTED BENT IN THE MIDDLE. IT WAS FURTHER REPORTED THAT BREACH IN THE STERILITY WAS ALLEGEDLY NOTED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19192880 ↗MalfunctionDec 28, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 22 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16059306 ↗
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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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