Dorado® DR80510Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741058578), received between Apr 13, 2017 and Apr 2, 2022 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL ANTEGRADE APPROACH, THE CONTRAST MEDIUM ALLEGEDLY LEAKED FROM THE HUB OF THE CATHETER. 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 13988339 ↗
• MalfunctionMay 25, 2021Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE AND LEAKED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11875924 ↗
• MalfunctionMay 20, 2021Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE ON THE FIRST INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT LEAKAGE WAS FOUND FROM THE CONNECTION PART OF THE BALLOON AND THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854654 ↗
• MalfunctionOct 30, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR80510 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763686 ↗
• MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR80510 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286717 ↗
• MalfunctionApr 20, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL DR80510 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE (B)(6) YEAR OLD PATIENT WEIGHED (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979801 ↗
• MalfunctionJul 22, 2019Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL: DR80510 PTA BALLOON DILATATION CATHETER ALLEGEDLY PEELED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A 71-YEAR-OLD MALE WHO WEIGHED 66 KILOGRAMS.

  Patient problems: No Patient Involvement

  MAUDE report 8812449 ↗
• MalfunctionNov 29, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AN ALLEGED LEAK WAS FOUND IN THE CATHETER SHAFT OF THE PTA BALLOON DURING THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118524 ↗
• MalfunctionAug 6, 2018Break; Material Rupture; Break; Material Rupture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7754858 ↗
• MalfunctionAug 2, 2018Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AN ALLEGED BREAK, AN ALLEGED LEAK WAS OBSERVED AT THE BALLOON GLUE JOINT. IT WAS FURTHER REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY WOULD NOT FULLY INFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7743177 ↗
• MalfunctionMay 30, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE FOR A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON WAS INFLATED TO 22 ATM'S AND AN X-RAY DEMONSTRATED CONTRAST ALLEGEDLY LEAKING FROM BETWEEN THE PTA BALLOON AND THE CATHETER SHAFT. THE DEVICE WAS REMOVED AND ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6599844 ↗
• MalfunctionApr 13, 2017Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY COULD NOT BE INFLATED. REPORTEDLY, THE BALLOON WAS REMOVED WITHOUT DIFFICULTIES FROM THE PATIENT AND THE HEALTH CARE PROVIDER FOUND THAT THE BALLOON INFLATION HUB HAD ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6492095 ↗