Dorado® DR4054Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741058486), received between May 30, 2017 and Dec 8, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 29 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A FISTULAGRAM ANGIOPLASTY PROCEDURE USING THE DORADO PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE WHEN REMOVED THE PRODUCT FROM THE PACKAGE AND PULLED THE STYLET AND PLASTIC CASING THE BALLOON ALLEGEDLY FELLED OFF FROM THE SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012955 ↗
• MalfunctionDec 18, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE ADHESIVE AT THE JOINT AT THE BASE OF THE SHAFT WAS NOT STRONG ENOUGH. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY LEAKED AIR AT THE SHAFT-BALLOON JUNCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20961750 ↗
• MalfunctionNov 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732747 ↗
• MalfunctionJun 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 12 ATM DURING FIRST DILATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574014 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A HOLE WAS ALLEGEDLY FOUND AT THE SHAFT OF THE CATHETER NEAR THE ROOT OF THE BALLOON UPON INFLATING AT 8ATM. IT WAS FURTHER REPORTED THAT THE SHAFT WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929125 ↗
• MalfunctionApr 21, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16783527 ↗
• MalfunctionDec 9, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, SALINE ALLEGEDLY LEAKED FROM THE TIP OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948605 ↗
• MalfunctionNov 26, 2022Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, BALLOON ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT BALLOON WAS REMOVED DURING THE SAME PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15866809 ↗
• MalfunctionSep 7, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CONTRAST MEDIUM ALLEGEDLY LEAKED FROM THE CATHETER SHAFT NEAR THE CONNECTION PART OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15368404 ↗
• MalfunctionJan 25, 2022Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT WAS ALLEGEDLY FOUND TO BE ROUGH APPROXIMATELY FIVE CM FROM THE TIP . THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342314 ↗
• MalfunctionJan 18, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CONTRAST MEDIUM ALLEGEDLY LEAKED FROM THE GUIDEWIRE LUMEN. IT WAS FURTHER REPORTED THAT ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13279275 ↗
• MalfunctionDec 28, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING INFLATION, CONTRAST LEAKAGE WAS ALLEGEDLY FOUND FROM THE CONNECTION BETWEEN THE SHAFT AND THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11075382 ↗
• MalfunctionOct 30, 2020Break; Material Frayed; Peeled/Delaminated; Material Rupture; Break; Material Frayed; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR4054 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK, LEAK, PEELED OR DELAMINATED AND RUPTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763802 ↗
• MalfunctionOct 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10670994 ↗
• MalfunctionOct 6, 2020Break; Leak/Splash; Material Rupture; Break; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE, FLUID LEAKS OCCURRED AFTER THE PROXIMAL END OF THE BALLOON. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10633317 ↗
• MalfunctionOct 5, 2020Break; Leak/Splash; Material Rupture; Break; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, FLUID LEAKS OCCURRED AFTER THE PROXIMAL END OF THE BALLOON. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10625075 ↗
• MalfunctionApr 15, 2020Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4054 PTA BALLOON DILATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM AND MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE (B)(6) MALE WAS (B)(6) .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965395 ↗
• MalfunctionJan 16, 2020Break; Leak/Splash; Break; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4054 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND A LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE THAT WEIGHED (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596990 ↗
• MalfunctionOct 16, 2019Break; Leak/Splash; Peeled/Delaminated; Break; Leak/Splash; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4054 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A LEAK, PEELED, AND A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198663 ↗
• MalfunctionOct 16, 2019Break; Leak/Splash; Break; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4054. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK AND LEAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198661 ↗
• MalfunctionJul 24, 2019Break; Leak/Splash; Break; Leak/Splash

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4054 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND A LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822928 ↗
• MalfunctionFeb 14, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY WOULD NOT FULLY INFLATE DURING THE FIRST INFLATION. THE HEALTH CARE PROVIDER REMOVED THE BALLOON CATHETER FROM THE PATIENT AND MADE ANOTHER INFLATION ATTEMPT OUTSIDE OF THE BODY WHICH ALLEGEDLY IDENTIFIED A LEAK AT THE PROXIMAL CATHETER-BALLOON BUTT JOINT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7271232 ↗
• MalfunctionSep 26, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DISTAL MARKER BAND OF THE BALLOON CATHETER ALLEGEDLY COULD NOT BE LOCATED. REPORTEDLY, THE HEALTH CARE PROVIDER COMPLETED THE PROCEDURE WITH THE SAME BALLOON CATHETER WITH SOME DIFFICULTY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6894902 ↗