Dorado® DR4074Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741058974), received between Jan 26, 2017 and Feb 25, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT ABOUT 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 21465116 ↗
• MalfunctionNov 30, 2024Material Frayed; Leak/Splash; Material Frayed; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS PRESSURIZED BUT THE PRESSURE DID NOT INCREASE. IT WAS FURTHER REPORTED THAT WHEN THE SHEATH WAS REMOVED AND CHECKED OUTSIDE THE BODY, AN AIR LEAKAGE WAS ALLEGEDLY FOUND AT THE SHAFT CONNECTION 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 20813645 ↗
• MalfunctionJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AT FIRST DILATION (10 ATM). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19769663 ↗
• MalfunctionApr 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102571 ↗
• MalfunctionMar 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE INTERNAL JUGULAR VEIN, THE BALLOON ALLEGEDLY RUPTURED AT 10 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 13684133 ↗
• MalfunctionMar 7, 2022Burst Container or Vessel; Material Frayed; Material Rupture; Burst Container or Vessel; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE INTERNAL JUGULAR VEIN, THE BALLOON ALLEGEDLY RUPTURED AT 10 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 13684091 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT OF THE DEVICE WAS ALLEGEDLY FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13520906 ↗
• MalfunctionDec 9, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA A RETROGRADE APPROACH, THE PTA BALLOON ALLEGEDLY HAD AN 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 12967478 ↗
• MalfunctionOct 28, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THESE MALFUNCTIONS INVOLVED THREE PATIENTS WITH NO CONSEQUENCES. TWO MALFUNCTIONS INVOLVED 56 YEAR OLD MALE AND THE REMAINING ONE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10752913 ↗
• MalfunctionJul 16, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796349 ↗
• MalfunctionOct 3, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN AN UPPER ARM FISTULA, AN ALLEGED LEAK WAS OBSERVED NEAR THE GLUE JOINT OF THE CATHETER SHAFT AND BALLOON, UPON REMOVAL FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 7932536 ↗
• MalfunctionJun 8, 2017Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT GUIDED FLUOROSCOPY DEMONSTRATED AN ALLEGED CONTRAST LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6625577 ↗
• MalfunctionJun 5, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED FROM THE PROXIMAL SIDE ONCE INFLATION PRESSURE WAS PROVIDED. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6613295 ↗
• MalfunctionJan 26, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RADIAL VEIN, AN ALLEGED LEAK WAS OBSERVED AT THE PROXIMAL END OF THE BALLOON INFLATION HUB DURING THE FIRST INFLATION. THE 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 6281862 ↗