Dorado® DR4084Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741059247), received between Jul 19, 2019 and Jun 19, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Break; Difficult to Open or Remove Packaging Material; Material Deformation; Break; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PLASTIC COVER ON THE PTA BALLOON ALLEGEDLY WOULD NOT COME OFF THE BALLOON. IT WAS FURTHER REPORTED THAT THE TECH TRIED TO REMOVE THE LITTLE COVER, AND IT WAS STUCK ON THE BALLOON. FURTHERMORE, WHEN THEY TRIED TO REMOVE IT THE BALLOON ALLEGEDLY BROKE FREE FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571312 ↗
• MalfunctionDec 28, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, BLOOD WAS ALLEGEDLY RETURNING INTO THE INFLATION DEVICE UPON NEGATIVE PRESSURE. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407773 ↗
• MalfunctionDec 22, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE RUPTURED UPON REMOVAL FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382003 ↗
• MalfunctionOct 14, 2023Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; 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 WOULD NOT RELEASE FROM THE PROTECTIVE SHEATH IN THE PACKAGING. IT WAS FURTHER REPORTED THAT THE BALLOON WAS PULLED OFF WITH KELLY¿S FORCEPS AND THE BALLOON ALLEGEDLY GOT PULLED AWAY AND WAS COMPLETELY DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936773 ↗
• MalfunctionJul 17, 2023Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BALLOON PROTECTOR ALLEGEDLY DID NOT SLIDE OFF THE BALLOON AND WAS FUSED TO THE BALLOON. IT WAS FURTHER REPORTED WHEN TRIED TO REMOVE THE COVER THE CATHETER ALLEGEDLY SNAPPED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331094 ↗
• MalfunctionJul 3, 2023Break; 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 RE-SHEATHER WAS ALLEGEDLY FUSED TO THE BALLOON AND PULLED THE BALLOON OFF THE SHAFT. 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 17248044 ↗
• MalfunctionMar 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT UPPER ARM FISTULA, THE PTA BALLOON ALLEGEDLY LEAKED CONTRAST UNDER FLUOROSCOPY UPON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  MAUDE report 13769758 ↗
• MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED WHILE REMOVING THE BALLOON OUT OF THE PLASTIC SLEEVE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12776828 ↗
• MalfunctionJul 14, 2020Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT CONSEQUENCES. THE 57 YEAR OLD MALE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273356 ↗
• MalfunctionJul 19, 2019Break; Leak/Splash; Break; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR4084 PTA BALLOON DILATATION CATHETER ALLEGEDLY LEAKED AT THE GLUE JOINT OF THE PROXIMAL END OF THE PTA BALLOON. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS CONCLUDED. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809122 ↗