Dorado® DR8064Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741058721), received between Oct 27, 2016 and Mar 2, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN DISTAL LEFT RADIAL ARTERY USING THE DORADO PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED DURING ARTERIAL BALLOON DILATATION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480370 ↗
• MalfunctionNov 3, 2023Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. 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 18063260 ↗
• MalfunctionOct 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BOTTOM HALF OF THE DEVICE WAS FOUND TO BE A GOLDEN YELLOW COLOR AND THE PACKAGE HAD ABSORBED SOME OIL. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS ALLEGEDLY SOAKED WITH A POPCORN OIL COLOR. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982010 ↗
• MalfunctionOct 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BOTTOM HALF OF THE DEVICE WAS FOUND TO BE A GOLDEN YELLOW COLOR AND THE PACKAGE HAD ABSORBED SOME OIL. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS ALLEGEDLY SOAKED WITH A POPCORN OIL COLOR. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981932 ↗
• MalfunctionFeb 8, 2023Break; Inflation Problem; Break; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318797 ↗
• MalfunctionFeb 7, 2023Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD AN INFLATION ISSUE AT THE FIRST INFLATION ATTAMEPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316340 ↗
• MalfunctionSep 7, 2022Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT THE FIRST INFLATION. IT WAS FURTHER REPORTED THAT LEAKAGE OF CONTRAST MEDIUM AND SALINE SOLUTION WAS NOTICED WHEN THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15368515 ↗
• MalfunctionAug 30, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AIR ALLEGEDLY LEAKED AT THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320216 ↗
• MalfunctionJan 3, 2022Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM IN THE FIRST INFLATION ATTEMPT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13140263 ↗
• MalfunctionJun 24, 2021Break; Material Rupture; Break; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12057228 ↗
• MalfunctionMay 12, 2021Leak/Splash; Material Rupture; Detachment of Device or Device Component; Leak/Splash; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM AND DETACHED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY LEAKED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811511 ↗
• MalfunctionMay 6, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. 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 11782506 ↗
• MalfunctionApr 29, 2021Break; Inflation Problem; Material Rupture; Break; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WOULD NOT REMAIN INFLATED AND ALLEGEDLY RUPTURED AT 12ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11743594 ↗
• MalfunctionMar 1, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395198 ↗
• MalfunctionOct 30, 2020Break; Leak/Splash; Material Rupture; Break; Leak/Splash; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR8064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED LEAK, RUPTURE, BREAK AND MATERIAL DEFORMATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763676 ↗
• MalfunctionOct 30, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8064 BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. 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 10762901 ↗
• MalfunctionApr 17, 2020Material Puncture/Hole; Retraction Problem; Detachment of Device or Device Component; Material Deformation; Material Puncture/Hole; Retraction Problem; Detachment of Device or Device Component; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL PUNCTURE/ HOLE, DETACHMENT OF DEVICE OR DEVICE COMPONENT, RETRACTION PROBLEM AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF 72 YEAR OLD MALE IS 140 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9974072 ↗
• MalfunctionJan 16, 2020Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8064. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND PEELED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597314 ↗
• MalfunctionOct 21, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE MALE PATIENT WAS 51 YEARS OLD AND WEIGHED 55 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215386 ↗
• MalfunctionOct 16, 2019Break; Material Rupture; Device-Device Incompatibility; Break; Material Rupture; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL DR8064 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RUPTURE, DEVICE-DEVICE INCOMPATIBILITY, BREAK, AND LEAK. THIS REPORT WAS RECEIVE FROM ONCE SOURCE. THIS DEVICE WAS USED IN A 69 YEAR OLD MALE PATIENT; WEIGHT WAS NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199306 ↗
• MalfunctionApr 10, 2019Break; Peeled/Delaminated; Material Rupture; Break; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL DR8064 PTA BALLOON DILATION CATHETER EXPERIENCED A BREAK, PEELING, AND MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS MALE AND PATIENT AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500305 ↗
• MalfunctionFeb 14, 2019Break; Material Puncture/Hole; Material Rupture; Break; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8340201 ↗
• MalfunctionMay 2, 2018Material Rupture; Material Rupture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7480070 ↗
• MalfunctionMar 27, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA, CONTRAST MEDIUM WAS ALLEGEDLY LEAKING AT THE GLUE JOINT OF THE BALLOON CATHETER AT APPROXIMATELY 20 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7375087 ↗
• MalfunctionMar 27, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT POST COVERED STENT (OTHER MANUFACTURER) PLACEMENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA), CONTRAST MEDIUM ALLEGEDLY LEAKED AT THE GLUE JOINT BETWEEN THE CATHETER SHAFT AND THE BALLOON WHEN THE BALLOON WAS INFLATED TO APPROXIMATELY 20 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7375085 ↗