Conquest® CQ5054Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741062803), received between May 12, 2017 and Sep 30, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952612 ↗
• MalfunctionAug 24, 2026Material Rupture

  On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty procedure using a Conquest balloon catheter. During an intraoperative balloon dilation procedure for an arteriovenous fistula in the patients right forearm, the high pressure balloon ruptured before reaching its rated burst pressure. The balloon was immediately replaced, and the procedure was completed successfully. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50401317 ↗
• MalfunctionAug 4, 2026Difficult to Remove; Material Rupture

  On (b)(6)2026, a patient underwent a percutaneous transluminal angioplasty (PTA) procedure using a Conquest balloon catheter for the treatment of an autologous arteriovenous fistula in the left forearm. During the procedure, the balloon catheter was advanced over the guidewire to the target lesion and subsequently ruptured during deflation at 20 atm. Following the balloon rupture, difficulty was encountered while retracting the balloon catheter through the introducer sheath. As a result, the balloon catheter and introducer sheath were removed together as a single unit. The procedure was subsequently completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50127311 ↗
• MalfunctionMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR A STENOTIC LESION OF THE RIGHT FOREARM ENDOLEAK, THE PTA BALLOON ALLEGEDLY LEAKED BALLOON CONTRAST AGENT WHICH PREVENTED NORMAL DILATATION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. HOWEVER, CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729006 ↗
• MalfunctionOct 22, 2024Material Rupture; Material Deformation; Material Rupture; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502909 ↗
• MalfunctionSep 12, 2024Burst Container or Vessel; Material Rupture; Improper or Incorrect Procedure or Method; Burst Container or Vessel; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ANGIOPLASTY PROCEDURE IN THE PROXIMAL ANASTOMOTIC STENOSIS VIA THE LEFT FOREARM OF RADIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 25 ATM. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206308 ↗
• MalfunctionNov 8, 2023Material Rupture; Unraveled Material; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE TO TREAT THE FISTULA VENOUS STENOSIS, THE PTA BALLOON WAS ALLEGEDLY RUPTURED LONGITUDINALLY AT 26 ATM DURING THE THIRD PRESSURIZATION. IT WAS FURTHER REPORTED THAT THE BALLOON COULD BE REMOVED SMOOTHLY AFTER THE RUPTURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18090268 ↗
• MalfunctionSep 7, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE WHEN DILATING THE ANASTOMOTIC STOMA TOWARDS THE PROXIMAL END TO TREAT THE FISTULA VENOUS STENOSIS, THE PTA BALLOON ALLEGEDLY RUPTURED IN THE FOURTH PRESSURIZATION ATTEMPT 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 17697566 ↗
• MalfunctionJul 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE OUTER PACKAGE OF THE BALLOON WAS OPENED AND FLUSHED WITH NORMAL SALINE. IT WAS FURTHER REPORTED THAT THE TIP WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17369546 ↗
• MalfunctionApr 28, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 30 ATM DURING THE THIRD INFLATION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830932 ↗
• MalfunctionMar 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED DURING PRESSURIZATION WITH PRESSURE PUMP. IT WAS FURTHER REPORTED THAT BLOOD VESSEL WAS ALLEGEDLY DAMAGED WHICH WAS RECOVERED AFTER COMPRESSION TO STOP BLEEDING. REPORTEDLY, THE DAMAGED BALLOON WAS REMOVED AND A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16634493 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693492 ↗
• MalfunctionDec 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PROXIMAL END OF THE CEPHALIC VEIN, PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13058434 ↗
• MalfunctionJul 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED 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 12097703 ↗
• MalfunctionOct 14, 2020Material Frayed; Peeled/Delaminated; Material Rupture; Material Frayed; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH FOREARM RADIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 ATM. 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 10678349 ↗
• MalfunctionJan 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ5054 CONQUEST PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MATERIAL RUPTURE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. PATIENT AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593430 ↗
• MalfunctionApr 15, 2019Peeled/Delaminated; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ5054 PTA BALLOON DILATATION CATHETER ALLEGEDLY HAD PEELED MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED ON THE PATIENT, WITH NO REPORTED INJURY. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515558 ↗
• MalfunctionFeb 14, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT UPON OPENING OF THE OUTER PACKAGING, THE DEVICE WAS ALLEGEDLY FOUND WITHOUT THE INNER PACKAGING. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8340291 ↗
• MalfunctionJul 2, 2018Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE UPPER ARM, THE PTA BALLOON ALLEGEDLY RUPTURED AT 30 ATM. THE BALLOON WAS REMOVED IN ITS ENTIRETY THROUGH THE SHEATH WITHOUT DIFFICULTY. THERE WAS NO REPORTED DETACHMENT OF BALLOON MATERIAL NOR ANY VESSEL DAMAGE. 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 7657373 ↗
• MalfunctionJul 2, 2018Leak/Splash; Peeled/Delaminated; Material Rupture; Leak/Splash; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A VENOUS ANASTOMOSIS, AFTER REMOVING THE PTA BALLOON FROM THE PATIENT, AN ALLEGED LEAK WAS FOUND ON THE PTA BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656096 ↗
• MalfunctionMar 21, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT AFTER APPROXIMATELY 16 BALLOON INFLATIONS OF AN AV GRAFT FISTULA WITHIN THE BRACHIAL VEIN, UPON REMOVAL OF THE DEVICE, THE HEALTH CARE PROVIDER ALLEGEDLY IDENTIFIED UNRAVELED BALLOON FIBERS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7360465 ↗
• MalfunctionMay 12, 2017Material Frayed; Peeled/Delaminated; Material Frayed; Peeled/Delaminated

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE FOR AV GRAFT STENOSIS, THE PTA BALLOON WAS INFLATED APPROXIMATELY EIGHT TIMES IN THE VENOUS SIDE TO APPROXIMATELY 20 ATM'S, AND AT THE CONCLUSION OF THE PROCEDURE, THE OUTER MATERIAL OF THE PTA BALLOON WAS ALLEGEDLY FRAYED AFTER THE CATHETER WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6565093 ↗