Dorado® DR4064Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741058714), received between May 16, 2017 and Nov 11, 2025 — classified as 32 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 32 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionSep 24, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE DORADO BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130416 ↗
• MalfunctionJun 10, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING A DORADO BALLOON IN HIGHLY CALCIFIED TARGET LESION IN THE RIGHT UPPER ARM VEIN. DURING THE PROCEDURE WHILE PASSING THROUGH THE GUIDEWIRE, THE PTA BALLOON WAS INSERTED, BUT IT ALLEGEDLY RUPTURED AT 3 ATM, BELOW THE SPECIFIED PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22173408 ↗
• MalfunctionJan 21, 2025Break; Material Frayed; Leak/Splash; Break; Material Frayed; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AIR LEAKAGE WAS ALLEGEDLY CONFIRMED FROM THE SHAFT CONNECTION PART ON THE FRONT SIDE OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21204811 ↗
• MalfunctionOct 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM DURING THE FIRST EXPANSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478709 ↗
• MalfunctionSep 3, 2024Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method; Material Deformation; Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AFTER THE BALLOON REACHED THE LESION THROUGH THE GUIDEWIRE, THE PTA BALLOON WAS UNABLE TO BE INFLATED AFTER THE PRESSURE PUMP CONTINUED TO PRESSURIZE THE BALLOON. IT WAS FURTHER REPORTED THAT THE BALLOON WAS WITHDRAWN FROM THE BODY, AND AFTER CHECKING THE BALLOON, IT WAS FOUND THAT THE PTA BALLOON WAS ALLEGEDLY LEAKING. REPORTEDLY, THE SURGEON WITHDREW THE BALLOON FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20123336 ↗
• MalfunctionJul 30, 2024Leak/Splash; Difficult to Remove; Material Rupture; Leak/Splash; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED RENAL ARTERY STENOSIS, IT WAS FOUND THAT THE PTA BALLOON ALLEGEDLY LEAKED DUE TO THE BALLOON RUPTURED AT 8 ATM AND COULD NOT BE IMPLANTED NORMALLY. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. FURTHERMORE, THE BALLOON AND THE INTRODUCER SHEATH WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19868860 ↗
• MalfunctionJan 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 11 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534004 ↗
• MalfunctionDec 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED DURING FIRST EXPANSION AT 7 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308390 ↗
• MalfunctionMar 2, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 18 ATM ON THE FIRST INFLATION ATTEMPT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465268 ↗
• MalfunctionOct 17, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT BRACHIAL ARTERY, THE PTA BALLOON ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613647 ↗
• MalfunctionJan 6, 2022Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA RETROGRADE APPROACH, THE PTA BALLOON ALLEGEDLY HAD INFLATION ISSUE. IT WAS FURTHER REPORTED THAT AIR WAS HEARD LEAKING FROM THE CONNECTION PART OF THE BALLOON AND THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173951 ↗
• MalfunctionAug 24, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE LEFT UPPER EXTREMITY UNDER ULTRASOUND GUIDANCE, THE PTA BALLOON ALLEGEDLY BROKE WHICH RESULTED IN FLUID LEAKAGE AT THE CONNECTION BETWEEN THE SHOULDER OF THE BALLOON AND THE STEM. 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 12358313 ↗
• MalfunctionJul 13, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM ON THE SECOND INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12156645 ↗
• MalfunctionJul 5, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE USING 6FR SHEATH AND 0.035 INCH GUIDE WIRE, THE CONTRAST MEDIUM WAS ALLEGEDLY LEAKED FROM THE GW LUMEN. 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 12116412 ↗
• MalfunctionJun 24, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE SHUNT, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20ATM. 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 12057224 ↗
• MalfunctionFeb 1, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM AT THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257168 ↗
• MalfunctionDec 9, 2020Break; Inflation Problem; Leak/Splash; Material Rupture; Break; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE BALLOON ALLEGEDLY FAILED TO INFLATE AT 24 ATM. IT WAS FURTHER REPORTED THAT CONTRAST MEDIUM ALLEGEDLY LEAKED FROM SHAFT OF BALLOON PROXIMAL OR GUIDEWIRE LUMEN. REPORTEDLY, 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 10973838 ↗
• MalfunctionNov 20, 2020Break; Peeled/Delaminated; Material Rupture; Break; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 24 ATM ON THE THIRD INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874554 ↗
• MalfunctionOct 28, 2020Break; Leak/Splash; Peeled/Delaminated; Break; Leak/Splash; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED SALINE LEAK, CIRCUMFERENTIAL BREAK AND PEELED PEBAX. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) KGS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10752893 ↗
• MalfunctionOct 28, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE AGE AND WEIGHT OF THE MALE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10748229 ↗
• MalfunctionJul 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR4064 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286740 ↗
• MalfunctionApr 15, 2020Break; Material Rupture; Break; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A MALE; WEIGHT AND AGE WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965457 ↗
• MalfunctionApr 15, 2020Break; Leak/Splash; Material Rupture; Break; Leak/Splash; Material Rupture

  THIS REPORT SUMMARIZE THREE MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL DR4064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965398 ↗