Dorado® DR8094Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741059445), received between Oct 31, 2016 and Jan 23, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Break; Peeled/Delaminated; Material Rupture; Unraveled Material; Detachment of Device or Device Component; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE DORADO BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY TORN AND THE BASE CATHETER COVERING STRIPPED AWAY FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158751 ↗
• MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING DORADO PTA CATHETER. DURING AN ANGIOPLASTY PROCEDURE, IT ALLEGEDLY BROKE OFF IN THE SHAFT AS IT WAS PULLING IT OUT OF THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159010 ↗
• MalfunctionOct 17, 2024Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Packaging Problem; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PACKAGING WAS ALLEGEDLY CRUSHED. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS DAMAGED. FURTHERMORE, THE BOX WAS ALLEGEDLY TORN ON SIDE AND BENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469557 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PROXIMAL END OF THE PTA BALLOON ALLEGEDLY SNAPPED IN THE PACKAGING BEFORE BEING OPENED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094590 ↗
• MalfunctionJan 8, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BREAK OFF ON THE WAY OUT OF THE PATIENT. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY GOT STUCK IN THE SHEATH DURING REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463293 ↗
• MalfunctionJun 10, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE , THE PTA BALLOON ALLEGEDLY HAD LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972574 ↗
• MalfunctionMar 30, 2021Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 14 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587285 ↗
• MalfunctionJul 16, 2020Break; Material Deformation; Break; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR8094 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK AND MATERIAL DEFORMATION. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, GENDER AND WEIGHT WAS NOT PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286926 ↗
• MalfunctionJan 16, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8094 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS MALE, AND THE WEIGHT IS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9598083 ↗
• MalfunctionJul 23, 2019Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR8094 PTA BALLOON DILATATION CATHETER ALLEGEDLY WAS DIFFICULT TO RETRACT THROUGH THE SHEATH AND DETACHED. THE DEVICES WERE USED WITH THE SHEATH AS A SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY. ONE PATIENT WAS AN (B)(6)-YEAR-OLD MALE WHO WEIGHED (B)(6) KILOGRAMS. AGE, WEIGHT, AND GENDER FOR THE OTHER PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817519 ↗
• MalfunctionApr 13, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN ALLEGED LEAK WAS OBSERVED AT THE BALLOON GLUE JOINT. REPORTEDLY, THERE WAS NO ISSUE RETRACTING THE BALLOON THROUGH THE SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429475 ↗
• MalfunctionFeb 21, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE MID ARM THE PTA BALLOON ALLEGEDLY WAS DIFFICULT TO DEFLATE. THERE WERE NO REPORTED RETRACTION DIFFICULTIES THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE PROCEDURE WAS CONCLUDED UPON REMOVAL OF THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287577 ↗
• MalfunctionDec 11, 2017Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN THE CEPHALIC ARCH AN ALLEGED PINHOLE RUPTURE OCCURRED ON THE THIRD INFLATION ATTEMPT AT 18 ATM. THERE WAS NO REPORTED RETRACTION ISSUE. 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 7106430 ↗
• MalfunctionAug 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE FIRST INFLATION, DURING PLACEMENT OF THE PTA BALLOON CATHETER, THE PROXIMAL MARKER BAND WAS ALLEGEDLY IDENTIFIED AS MISSING BY THE HEALTH CARE PROVIDER. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. THE BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6772564 ↗
• MalfunctionFeb 14, 2017Break; Kinked; Break; Kinked

  IT WAS REPORTED THAT WHILE INSERTING THE PTA BALLOON THROUGH A G-TUBE THE BALLOON ALLEGEDLY BENT AND THEN BROKE FROM THE CATHETER SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330647 ↗
• MalfunctionJan 4, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LESION IN THE RIGHT BRACHIOCEPHALIC VEIN, A LEAK WAS IDENTIFIED FOLLOWING THE FIRST INFLATION OF THE PTA BALLOON. 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 6221986 ↗
• MalfunctionOct 31, 2016Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER WAS ALLEGEDLY DIFFICULT TO DEFLATE AFTER USE IN THE LEFT SUBCLAVIAN VEIN. THERE WAS NO REPORTED RETRACTION ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6068327 ↗