Dorado® DR8074Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741058981), received between Nov 9, 2016 and Jul 14, 2025 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A 64-YEAR-OLD FEMALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE DORADO PTA BALLOON CATHETER. DURING THE PROCEDURE, BALLOON THAT AFTER REACHING 15 ATM, IT BEGAN TO LOSE PRESSURE. IT WAS FURTHER REPORTED THAT WHEN THE BALLOON WAS REMOVED, IT WAS FOUND THAT IT WAS LOSING PRESSURE AT THE BASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492824 ↗
• MalfunctionJan 21, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE OUTER AND INNER PACKAGING OF THE PTA BALLOON WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196162 ↗
• MalfunctionJan 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE ADVANCED CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON CATHETER RUPTURED APPROXIMATELY AT 20 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191069 ↗
• MalfunctionJun 26, 2023Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198808 ↗
• MalfunctionMar 17, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA TORTUOUS CEPHALIC VEIN, THE BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE AT 20 ATM AND VISIBLE LEAKS OF CONTRAST AGENT WAS ALLEGEDLY OBSERVED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE SHEATH. THE BALLOON WAS REPLACED FOR DILATATION AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13797947 ↗
• MalfunctionSep 20, 2021Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE SHUNT, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. 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 12496877 ↗
• MalfunctionMay 26, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY LEAKED AT THE POINT BY THE GUIDEWIRE LIGHT DURING INFLATION. 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 11883157 ↗
• MalfunctionFeb 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE HUB OF THE GUIDEWIRE ALLEGEDLY DETACHED AFTER THE FIRST INFLATION ATTEMPT. 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 11259020 ↗
• MalfunctionDec 17, 2020Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE AT 20 ATM. IT WAS FURTHER REPORTED THAT DISTAL END OF THE BALLOON SHAFT WAS ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11025948 ↗
• MalfunctionNov 19, 2020Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10873006 ↗
• MalfunctionOct 28, 2020Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR8074 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND PEELED /DELAMINATED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) YEARS OLD MALE PATIENT WEIGHT WAS NO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10752896 ↗
• MalfunctionJul 16, 2020Peeled/Delaminated; Material Rupture; Material Deformation; Peeled/Delaminated; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR8074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION, MATERIAL RUPTURE, PEELED AND MATERIAL SPLIT. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. FEMALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286773 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8074 PTA BALLOON DILATATION CATHETER ALLEGEDLY MATERIAL RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL THREE EVENTS HAD NO REPORTED PATIENT INJURY. ONE PATIENT IS FEMALE; HOWEVER, THE OTHER PATIENTS AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965320 ↗
• MalfunctionJan 16, 2020Break; Material Rupture; Break; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8074 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE (B)(6) YEAR FEMALE WAS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597323 ↗
• MalfunctionOct 16, 2019Break; Break

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6) YEARS OLD AND WEIGHS 63 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198954 ↗
• MalfunctionJul 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812451 ↗
• MalfunctionSep 10, 2018Break; Material Rupture; Material Deformation; Break; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE AXILLARY VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT TEN ATM. THE PTA 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 7861060 ↗
• MalfunctionMar 30, 2018Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT A BALLOON WAS ALLEGEDLY DILATED FROM 4 ATM TO 20 ATM TO TREAT A THROMBOTIC LESION. WHEN THE BALLOON WAS INFLATED TO 20 ATM THE BALLOON ALLEGEDLY RUPTURED. REPORTEDLY, THE HEALTH CARE PROVIDER USED ANOTHER BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7387376 ↗
• InjuryNov 14, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN AN ALLEGED LEAK WAS OBSERVED AT THE GLUE JOINT OF THE BALLOON CATHETER. REPORTEDLY, A VESSEL DISSECTION WAS OBSERVED WHEN THE BALLOON WAS INFLATED TO 20 ATM FOR THE SECOND ATTEMPT. IT WAS FURTHER REPORTED THAT THERE WAS NUMBNESS IN THE PATIENTS THUMB DURING THE PROCEDURE. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED AS ASYMPTOMATIC AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7030187 ↗
• MalfunctionNov 9, 2016Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, A BREAK WAS ALLEGEDLY IDENTIFIED ON THE CATHETER SHAFT OF THE PTA BALLOON DEVICE ON THE LAST INFLATION. THERE WAS NO REPORTED RETRACTION ISSUES. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6091605 ↗