Dorado® DR80610Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741058837), received between Oct 27, 2017 and Oct 3, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CONTRAST LEAKAGE WAS OBSERVED AROUND THE PROXY SIDE OF THE BALLOON AT 19 ATM. IT WAS FURTHER REPORTED THAT THE BONDING ALLEGEDLY CAME LOOSE AND THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357690 ↗
• MalfunctionOct 2, 2023Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850122 ↗
• MalfunctionFeb 7, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FRACTURED COMING OUT THROUGH STENTS AND SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316203 ↗
• MalfunctionJul 7, 2022Break; Material Rupture; Break; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14942567 ↗
• MalfunctionOct 28, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR80610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10748205 ↗
• MalfunctionJul 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL DR80610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286854 ↗
• MalfunctionJul 16, 2020Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR80610 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED INFLATION PROBLEMS, BALLOON DETACHMENT AND WAS DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10286774 ↗
• MalfunctionJul 16, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT THE MODEL DR80610 PTA DILATATION CATHETER ALLEGEDLY FAILED TO INFLATE AND BALLOON RUPTURED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, SEX AND WEIGHT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286733 ↗
• MalfunctionApr 20, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL DR80610, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECIEVED FROM MULTIPLE SOURCES. THESE MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. THE PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9977310 ↗
• MalfunctionJan 16, 2020Break; Material Rupture; Break; Material Rupture

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR80610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL THREE EVENTS HAD NO REPORTED PATIENT INJURY. OF THE THREE REPORTED PATIENT, ONE PATIENT IS MALE, (B)(6) YEARS OLD AND WEIGHT IS UNKNOWN; HOWEVER, ALL OTHER PATIENT AGE, WEIGHT, GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597255 ↗
• MalfunctionJan 16, 2020Break; Inflation Problem; Break; Inflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL DR80610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED INFLATION ISSUE AND A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597170 ↗
• MalfunctionJan 16, 2020Break; Material Puncture/Hole; Break; Material Puncture/Hole

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR80610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK AND PUNCTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597124 ↗
• MalfunctionOct 16, 2019Break; Difficult to Remove; Retraction Problem; Material Rupture; Break; Difficult to Remove; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DR80610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK, RETRACTION PROBLEMS, AND MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198749 ↗
• MalfunctionAug 22, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PROXIMAL MARKER BAND OF THE PTA BALLOON WAS ALLEGEDLY LOCATED IN THE CENTER OF BALLOON AFTER INSERTION INTO THE PATIENT. 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 7806474 ↗
• MalfunctionAug 10, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT FOLLOWING AN ANGIOPLASTY PROCEDURE IN THE AVG GRAFT, AFTER REMOVAL FROM THE PATIENT, A LEAK WAS ALLEGEDLY IDENTIFIED ON THE CATHETER OF THE PTA BALLOON. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773647 ↗
• MalfunctionJun 12, 2018Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT WHEN INFLATING A PTA BALLOON TO 22 ATM, THE BALLOON ALLEGEDLY WAS UNABLE TO INFLATE TO THE DESIRED PRESSURE, NOT EXCEEDING 20 ATM. IT WAS FURTHER ALLEGED THAT AN ATTEMPT TO INFLATE THE BALLOON TO 12 ATM WAS SUCCESSFUL. REPORTEDLY, UPON REMOVAL, DAMAGE WAS FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7593090 ↗
• MalfunctionNov 15, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT WHEN FLUSHING THE DEVICE DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, AN ALLEGED LEAK WAS OBSERVED FROM THE PTA BALLOON CATHETER SHAFT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7035979 ↗
• MalfunctionOct 27, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE VASCULAR ACCESS INTERVENTION THERAPY FOR STENOSIS NEAR THE ANASTOMOTIC PART OF THE ARTERIOVENOUS FISTULA IN THE FOREARM, THE HEALTH CARE PROVIDER INSERTED THE DEVICE FROM THE ANASTOMOTIC PART TO THE CENTRAL SIDE OF THE ARTERY, AND INFLATED THE BALLOON AT THE POSITION WHERE THE BALLOON TIP ENTERED THE ARTERY FROM THE ANASTOMOTIC PART. AFTER THE DILATION WAS SUCCESSFULLY PERFORMED AT 22 ATM, AN UNUSUAL NOISE WAS ALLEGEDLY HEARD THIRTY SECONDS AFTER INFLATING THE BALLOON. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND TESTED FOR DEFICIENCIES. LEAKAGE AND BALLOON DAMAGE WAS ALLEGEDLY OBSERVED ON THE PTA BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6984298 ↗