Dorado® DR8084Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741059254), received between Oct 28, 2016 and Dec 15, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (16 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionAug 5, 2025Break; Inflation Problem; Break; Inflation Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DORADO PTA BALLOON ALLEGEDLY COULD NOT BE EXPANDED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715306 ↗
• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE DORADO PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, SHAFT WAS ALLEGEDLY BROKEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291144 ↗
• MalfunctionJan 8, 2024Break; 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

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE REMOVED FROM THE PLASTIC SHEATH AROUND THE BALLOON. IT WAS FURTHER REPORTED THAT THE BALLOON WAS COMPLETELY DETACHED FROM THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462702 ↗
• MalfunctionOct 13, 2022Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF SHUNT, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM ON THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15593988 ↗
• MalfunctionNov 1, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PACKAGE OF THE DEVICE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728550 ↗
• MalfunctionJun 10, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972575 ↗
• MalfunctionMay 18, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 13ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841685 ↗
• MalfunctionApr 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE THE BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647732 ↗
• MalfunctionFeb 26, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD 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 11383424 ↗
• MalfunctionJan 20, 2021Break; Peeled/Delaminated; Material Rupture; Break; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE, BREAK,LEAK AND PEELED OR DELAMINATED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205191 ↗
• MalfunctionOct 27, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8084 PTA DILATATION CATHETER ALLEGEDLY RUPTURED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10740618 ↗
• MalfunctionJul 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL DR8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286800 ↗
• MalfunctionJan 16, 2020Break; Material Rupture; Break; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS A 67 YEAR OLD MALE WITH WEIGHT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597321 ↗
• MalfunctionJul 24, 2019Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY BECAME STUCK, AND THE DISTAL TIP DETACHED INSIDE THE INTRODUCER SHEATH. THE BALLOON AND SHEATH WERE REMOVED AS A SINGLE UNIT. NO FURTHER DEVICES WERE NEEDED TO FINISH THE PROCEDURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS A 29-YEAR-OLD FEMALE WHO WEIGHED 119 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824315 ↗
• MalfunctionJul 24, 2019Break; Material Deformation; Break; Material Deformation

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE 74 YEAR OLD MALE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8824241 ↗
• MalfunctionNov 29, 2018Break; Material Frayed; Leak/Splash; Break; Material Frayed; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A STENOSIS, THE PTA BALLOON ALLEGEDLY HAD A LEAK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118527 ↗
• MalfunctionAug 6, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN AN AV FISTULA THE PTA BALLOON CATHETER SHAFT ALLEGEDLY LEAKED BEFORE INFLATION. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7755160 ↗
• MalfunctionMay 18, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT WHILE FLUSHING, AN ALLEGED LEAK WAS FOUND ON THE PTA BALLOON; THEREFORE, THE DEVICE WAS NOT USED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7526894 ↗
• MalfunctionFeb 7, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN ALLEGED LEAK WAS OBSERVED COMING FROM THE CATHETER SHAFT OF THE PTA BALLOON. 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 7249809 ↗
• MalfunctionSep 13, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, TWO ALLEGED LEAKS WERE OBSERVED ON THE PTA BALLOON CATHETER. 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 6863867 ↗
• MalfunctionAug 22, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AN ALLEGED LEAK WAS FOUND BETWEEN THE CATHETER SHAFT AND THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6812145 ↗
• MalfunctionMay 9, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE INFLATION HUB OF THE PTA CATHETER ALLEGEDLY BECAME DETACHED DURING THE SECOND INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556111 ↗
• MalfunctionApr 4, 2017Material Frayed; Material Frayed

  IT WAS REPORTED AFTER COMPLETION OF AN ANGIOPLASTY PROCEDURE IN A SEVERELY CALCIFIED STENOTIC LESION, THE TIP OF THE PTA CATHETER WAS ALLEGEDLY FRAYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6457374 ↗