DoradoRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 49 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 387
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 49 models of Dorado by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 387 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2016 and Apr 14, 2026 — classified as 6 injuries, 381 malfunctions.
The most frequently reported specific device problem is “Break” (219 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Dorado problems
Device problems
- Break219
- Material Rupture140
- Leak/Splash94
- Detachment of Device or Device Component72
- Retraction Problem51
- Inflation Problem32
- Material Deformation22
- Difficult to Remove17
Patient problems
- No Consequences Or Impact To Patient190
- No Clinical Signs, Symptoms or Conditions181
- No Patient Involvement10
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Perforation of Vessels1
- Pseudoaneurysm1
- Vascular Dissection1
Dorado models
49 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dorado® DR80104Catheter, angioplasty, peripheral, transluminal52 reports
- Dorado® DR4064CATHETER, PERCUTANEOUS32 reports
- Dorado® DR4054Catheter, angioplasty, peripheral, transluminal29 reports
- Dorado® DR8064CATHETER, PERCUTANEOUS28 reports
- Dorado® DR8084CATHETER, PERCUTANEOUS28 reports
- Dorado® DR8074CATHETER, PERCUTANEOUS20 reports
- Dorado® DR8054CATHETER, PERCUTANEOUS19 reports
- Dorado® DR80610Catheter, angioplasty, peripheral, transluminal18 reports
- Dorado® DR8094Catheter, angioplasty, peripheral, transluminal17 reports
- Dorado® DR4074Catheter, angioplasty, peripheral, transluminal14 reports
- Dorado® DR80510CATHETER, PERCUTANEOUS12 reports
- Dorado® DR4084Catheter, angioplasty, peripheral, transluminal10 reports
- Dorado® DR8086CATHETER, PERCUTANEOUS7 reports
- Dorado® DR8098CATHETER, PERCUTANEOUS7 reports
- Dorado® DR8044Catheter, angioplasty, peripheral, transluminal6 reports
- Dorado® DR135610Catheter, angioplasty, peripheral, transluminal6 reports
- Dorado® DR8088CATHETER, PERCUTANEOUS6 reports
- Dorado® DR135510CATHETER, PERCUTANEOUS5 reports
- Dorado® DR13564Catheter, angioplasty, peripheral, transluminal5 reports
- Dorado® DR8076Catheter, angioplasty, peripheral, transluminal5 reports
- Dorado® DR8056CATHETER, PERCUTANEOUS4 reports
- Dorado® DR8078Catheter, angioplasty, peripheral, transluminal4 reports
- Dorado® DR80810CATHETER, PERCUTANEOUS4 reports
- Dorado® DR80108Catheter, angioplasty, peripheral, transluminal4 reports
- Dorado® DR13552Catheter, angioplasty, peripheral, transluminal3 reports
- Dorado® DR13554Catheter, angioplasty, peripheral, transluminal3 reports
- Dorado® DR135710Catheter, angioplasty, peripheral, transluminal3 reports
- Dorado® DR13582CATHETER, PERCUTANEOUS3 reports
- Dorado® DR135104Catheter, angioplasty, peripheral, transluminal3 reports
- Dorado® DR8042Catheter, angioplasty, peripheral, transluminal2 reports
- Dorado® DR4044CATHETER, PERCUTANEOUS2 reports
- Dorado® DR13556Catheter, angioplasty, peripheral, transluminal2 reports
- Dorado® DR8066Catheter, angioplasty, peripheral, transluminal2 reports
- Dorado® DR8068Catheter, angioplasty, peripheral, transluminal2 reports
- Dorado® DR13572Catheter, angioplasty, peripheral, transluminal2 reports
- Dorado® DR8082CATHETER, PERCUTANEOUS2 reports
- Dorado® DR13584CATHETER, PERCUTANEOUS2 reports
- Dorado® DR80102CATHETER, PERCUTANEOUS2 reports
- Dorado® DR135102Catheter, angioplasty, peripheral, transluminal2 reports
- Dorado® DR8034Catheter, angioplasty, peripheral, transluminal1 report
- Dorado® DR8058CATHETER, PERCUTANEOUS1 report
- Dorado® DR4062CATHETER, PERCUTANEOUS1 report
- Dorado® DR13562Catheter, angioplasty, peripheral, transluminal1 report
- Dorado® DR12064CATHETER, PERCUTANEOUS1 report
- Dorado® DR120610CATHETER, PERCUTANEOUS1 report
- Dorado® DR80710Catheter, angioplasty, peripheral, transluminal1 report
- Dorado® DR8092CATHETER, PERCUTANEOUS1 report
- Dorado® DR4094Catheter, angioplasty, peripheral, transluminal1 report
- Dorado® DR13568Catheter, angioplasty, peripheral, transluminal1 report
Recent Dorado adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Break; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE DORADO BALLOON CATHETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON CATHETER ALLEGEDLY LOSS THE INTEGRITY AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24870031 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, WHILE FLUSHING THE BALLOON ALLEGEDLY CAME OFF OF THE SHAFT. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660488 ↗MalfunctionMar 2, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN DISTAL LEFT RADIAL ARTERY USING THE DORADO PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED DURING ARTERIAL BALLOON DILATATION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480370 ↗MalfunctionJan 23, 2026Break; Peeled/Delaminated; Material Rupture; Unraveled Material; Detachment of Device or Device Component; Material Split, Cut or Torn
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 TORN AND THE BASE CATHETER COVERING STRIPPED AWAY FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24158751 ↗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 ↗MalfunctionDec 15, 2025Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material
ON (B)(6) 2025, PRIOR TO AN ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON, IT WAS REPORTED THAT THE METAL DILATOR AND PLASTIC BALLOON COVERING COULD NOT BE REMOVED. IT WAS FURTHER NOTED THAT THE BALLOON HAD DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23800672 ↗MalfunctionDec 8, 2025Break; Material Rupture; Break; Material Rupture
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 HAD A PINHOLE RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23753060 ↗MalfunctionDec 8, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON AT ARTERIOVENOUS ANASTOMOSIS SITE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE SHAFT AND BALLOON SECTION GOT TEARED APART. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739786 ↗MalfunctionDec 5, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON FOR AVG THROMBOLYSIS. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY HAD PINHONE RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724698 ↗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 ↗MalfunctionNov 11, 2025Material Rupture; Material Rupture
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 RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23521053 ↗MalfunctionOct 27, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A 43-YEAR-OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389310 ↗MalfunctionOct 22, 2025Material Rupture; Material Rupture
ON (B)(6) 2025 A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING DORADO. IT WAS REPORTED THAT DURING THE PROCEDURE, BALLOON RUPTURE OCCURRED AT A PRESSURE OF 16 ATM. THE RUPTURE WAS IDENTIFIED DURING THE INFLATION PHASE AFTER THE BALLOON HAD BEEN INSERTED INTO THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23355684 ↗MalfunctionOct 17, 2025Break; Inflation Problem; Material Deformation; Break; Inflation Problem; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING A DORADO BALLOON. DURING THE PROCEDURE THE BALLOON ALLEGEDLY FAILED TO EXPAND AT THE LESION SITE. INSTEAD, THE SAME PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320877 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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