Dorado® DR80104Recalls & reported problems
Bard Peripheral Vascular, Inc. · Dorado® PTA Balloon Dilatation Catheter 10 mm x 40 mm, 80 cm Catheter · Class 2
Quick summary
This is a Bard Dorado PTA balloon dilatation catheter, used to open narrowed peripheral arteries during angioplasty. Most of the 53 reports describe the balloon breaking or coming apart from its shaft during the procedure, and sometimes being hard to remove. Three reports involved an injury; no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00801741059544), received between Oct 13, 2016 and Dec 30, 2025 — classified as 3 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (30 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Retraction Problem30
- Detachment of Device or Device Component27
- Break24
- Difficult to Remove6
- Material Rupture5
- Deflation Problem3
- Device Damaged by Another Device2
- Inflation Problem2
Patient problems
- No Consequences Or Impact To Patient28
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient2
- Perforation of Vessels1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Break; Failure to Advance; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material; Material Deformation; Break; Failure to Advance; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DORADO PTA BALLOON ALLEGEDLY BENT/BROKEN AT THE BASE. IT WAS FURTHER REPORTED THAT IT WAS VERY DIFFICULT TO REMOVE THE PIN AND COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920471 ↗MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE THROUGH THE DORADO PTA BALLOON. DURING THE PROCEDURE, IT WAS FOUND THAT THE BALLOON ALLEGEDLY PULLS OFF THE SHAFT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904105 ↗MalfunctionNov 14, 2025Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE DORADO BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23552667 ↗MalfunctionSep 15, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051307 ↗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 23036585 ↗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 23036578 ↗MalfunctionJul 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT PREPPED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE DORADO PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON WAS SEPARATED FROM THE PLASTIC PIECE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22662495 ↗MalfunctionApr 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102566 ↗MalfunctionApr 8, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19057342 ↗MalfunctionSep 4, 2023Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY RECEIVED IN BROKEN BOX WITH PRODUCT VISIBLE, WHICH WAS UNABLE TO BE USED. IT WAS FURTHER REPORTED THAT THE PACKAGE WAS FOUND TO BE CUT OPENED AND FOLDED IN HALF. FURTHERMORE, THE DEVICE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17676380 ↗MalfunctionApr 13, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY GOT STUCK IN THE SHEATH DURING REMOVAL. IT WAS FURTHER REPORTED THAT BALLOON CATHETER WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14099866 ↗MalfunctionFeb 22, 2022Break; Break
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE IN THE FISTULA REGION, THE CATHETER SHAFT ALLEGEDLY FOUND TO BE CRACKED PROXIMAL TO THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13576915 ↗MalfunctionNov 3, 2021Break; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Break; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY TORE OUT THE CATHETER. IT WAS FURTHER REPORTED THAT THE DEVICE DETACHED AND WAS DIFFICULT TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12742753 ↗MalfunctionNov 3, 2021Break; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Break; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY TORE OUT THE CATHETER. IT WAS FURTHER REPORTED THAT THE DEVICE DETACHED AND WAS DIFFICULT TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12742752 ↗InjuryJul 27, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED AND RUPTURED AT THE CONNECTOR PART OF THE BALLOON AND THE CATHETER. IT WAS FURTHER REPORTED THAT THE BLOOD VESSEL WAS FOUND RUPTURED AND OOZING BLOOD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels
MAUDE report 12230561 ↗MalfunctionMay 5, 2021Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE BALLOON ALLEGEDLY BROKE OFF IN THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY STUCK IN THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11775715 ↗MalfunctionApr 15, 2021Break; Retraction Problem; Material Separation; Break; Retraction Problem; Material Separation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY SEPARATED FROM THE SHAFT OF THE CATHETER AND COULD NOT BE REMOVED FROM THE SHEATH. IT WAS FURTHER REPORTED THAT THE ENTIRE SHEATH AND BALLOON WERE TAKEN OUT TOGETHER AND A NEW SHEATH WAS INSERTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11670371 ↗MalfunctionJan 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON SEPARATED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11199366 ↗MalfunctionOct 26, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL DR80104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT AND DIFFICULT TO REMOVE. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE MALE PATIENT IS (B)(6) YEARS OLD AND WEIGHS (B)(6) KGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10735839 ↗MalfunctionOct 14, 2020Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD DEFLATION PROBLEM. IT WAS FURTHER REPORTED THAT THE PHYSICIAN USED A 20 CC SYRINGE TO INJECT AND ASPIRATE ON THE BALLOON TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10677927 ↗MalfunctionOct 12, 2020Break; Retraction Problem; Break; Retraction Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY GOT STUCK IN SHEATH AFTER USAGE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10667054 ↗MalfunctionOct 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DETACHED FROM THE CATHETER. IT WAS FURTHER REPORTED THAT BALLOON WAS SUCCESSFULLY RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10659194 ↗MalfunctionOct 9, 2020Break; Retraction Problem; Break; Retraction Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE DEVICE ALLEGEDLY STUCK IN SHEATH AFTER USAGE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10657793 ↗MalfunctionJul 16, 2020Retraction Problem; Retraction Problem
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR80104 PTA DILATATION CATHETER ALLEGEDLY GOT STUCK INSIDE THE SHEATH. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE TWO MALFUNCTIONS ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10286853 ↗MalfunctionJul 16, 2020Break; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Break; Difficult to Remove; Detachment of Device or Device Component; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR80104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE COMPONENT, MATERIAL DEFORMATION AND DIFFICULT TO REMOVE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE FEMALE PATIENT IS 84 YEARS OLD AND WEIGHS 116 POUNDS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10286805 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.