Dorado® DR8054Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741058493), received between Feb 13, 2017 and Jun 24, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Break; Burst Container or Vessel; Difficult to Remove; Break; Burst Container or Vessel; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR AN ANGIOPLASTY PROCEDURE USING A DORADO BALLOON. DURING THE PROCEDURE, THE BALLOON-SHAFT JUNCTION BREAKS WHILE IN USE BELOW RBP AND SO IT WAS DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313244 ↗
• MalfunctionNov 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY PRESSURIZED TO 10 ATM, AFTER WHICH THE PRESSURE DID NOT INCREASE. IT WAS FURTHER REPORTED THAT WHEN THE BALLOON WAS RETRIEVED AND PRESSURIZED EXTERNALLY, AND ALLEGEDLY A SMALL AMOUNT OF LEAKAGE WAS CONFIRMED FROM THE BALLOON SHOULDER. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809069 ↗
• MalfunctionJul 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION VIA IPSILATERAL APPROACH, BALLOON WAS RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747913 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND TO BE DEFECTIVE, AND THE TIP WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18280928 ↗
• MalfunctionFeb 8, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE LEAKAGE OF CONTRAST MEDIUM WAS ALLEGEDLY FOUND FROM THE CONNECTION PART OF THE CATHETER SHAFT AND THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325902 ↗
• MalfunctionJul 7, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DEFECTIVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14942111 ↗
• MalfunctionMay 25, 2022Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ANGIOPLASTY PROCEDURE VIA THE RIGHT UPPER ARM, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT THE DISTAL END. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14494705 ↗
• MalfunctionApr 2, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE CONTRAST MEDIUM ALLEGEDLY LEAKED FROM THE HUB OF THE CATHETER AT 14 ATM. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13987259 ↗
• MalfunctionFeb 16, 2021Break; Material Rupture; Break; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331408 ↗
• MalfunctionJan 4, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE SUBCLAVIAN VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THE LESION WAS MILDLY CALCIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106477 ↗
• MalfunctionJan 4, 2021Break; Leak/Splash; Material Rupture; Break; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE SUBCLAVIAN VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THE LESION WAS MILDLY CALCIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106475 ↗
• MalfunctionApr 17, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8054 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9975355 ↗
• MalfunctionApr 17, 2020Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8054 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND PEELING/DELAMINATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE WEIGHT AND AGE OF THE MALE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9973874 ↗
• MalfunctionApr 12, 2019Break; Material Rupture; Break; Material Rupture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL DR8054 PTA DILATATION CATHETER EXPERIENCED AN UNCOMPLICATED BALLOON RUPTURE AND A BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509804 ↗
• MalfunctionJul 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN FISTULAPLASTY THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733703 ↗
• MalfunctionNov 21, 2017Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING TREATMENT FOR A SHUNT, THE PTA BALLOON CATHETER ALLEGEDLY COULD NOT BE RETRACTED THROUGH THE 5FR SHEATH. THE BALLOON AND SHEATH WERE REMOVED AS A SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7049719 ↗
• MalfunctionJun 22, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE THE CATHETER SHAFT ALLEGEDLY LEAKED WHILE ATTEMPTING TO FLUSH THE BALLOON. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6662280 ↗
• MalfunctionJun 13, 2017Break; Kinked; Break; Kinked

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE SHAFT OF THE PTA CATHETER ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6637585 ↗
• MalfunctionFeb 13, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE BALLOON CONNECTION HUB ALLEGEDLY DETACHED FROM THE CATHETER SHAFT. REPORTEDLY THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6327799 ↗