Conquest® CQ5064Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00801741062872), received between Feb 27, 2017 and Sep 28, 2026 — classified as 1 injury, 68 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (60 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921287 ↗
• MalfunctionApr 30, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043345 ↗
• MalfunctionFeb 27, 2026Break

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST PTA BALLOON. DURING THE PROCEDURE, THE BALLOON MATERIAL ALLEGEDLY SEPARATES FROM THE CATHETER DUE TO POOR ADHESION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466252 ↗
• MalfunctionNov 3, 2025Break; Material Rupture; Break; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER BY ULTRASOUND-GUIDED THROUGH THE SITE OF UPPER LIMB VEIN TO ACCESS THE CEPHALIC VEIN. DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY RUPTURED AT 14 ATM. AND THERE WAS BLOOD IN THE PRESSURE PUMP DURING RETRIEVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448356 ↗
• MalfunctionSep 25, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, UPON INFLATION TO 26 ATMOSPHERES FOR THE THIRD TIME, AIR LEAKAGE OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23140755 ↗
• MalfunctionMay 16, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025 DURING AN ANGIOPLASTY PROCEDURE IN LEFT FOREARM AVF SURGERY, STENOSIS IN THE AVF PUNCTURE AREA AND 2 YEARS POST PROCEDURE SAME INCISION SITE WAS SELECTED FOR A FISTULA VEIN ACCESS, THE PTA BALLOON ALLEGEDLY STARTS TO LEAK, THE RUPTURE OF THE BALLOON IS CONSIDERED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033298 ↗
• MalfunctionApr 30, 2025Material Rupture; Difficult to Open or Remove Packaging Material; Material Rupture; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A LEAKAGE AFTER DILATATION AND PRESSURIZATION TO 27 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932199 ↗
• MalfunctionApr 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED AT THE ANTERIOR SEGMENT OF THE DEVELOPER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736439 ↗
• MalfunctionMar 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 25 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545898 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE DETACHED PART WAS STILL ATTACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21522731 ↗
• MalfunctionJan 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD A LEAKAGE AFTER PRESSURIZATION UP TO 25 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270915 ↗
• MalfunctionDec 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WAS LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21024646 ↗
• MalfunctionSep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED ANGIOPLASTY PROCEDURE VIA RADIAL ARTERY PUNCTURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 25 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206370 ↗
• MalfunctionSep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT INTERNAL FOREARM FISTULA, THE PTA BALLOON ALLEGEDLY LEAKED AT 28 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20198944 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE VASCULAR SHEATH WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824551 ↗
• MalfunctionMay 15, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TAIL END ALLEGEDLY DISCONNECTED WHEN THE DEVICE WAS WITHDRAWN. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19317980 ↗
• MalfunctionMar 26, 2024Break; Leak/Splash; Difficult to Remove; Material Rupture; Break; Leak/Splash; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, WHEN THE PRESSURE WAS PUMPED TO 8 ATM DURING REPEAT DILATATION, PRESSURE PUMP ABNORMALITY WAS NOTICED AND BLOOD WAS ALLEGEDLY SEEN ON GENTLE RETRACTION AND THE PTA BALLOON ALLEGEDLY COULD NOT BE FULLY RETRACTED. REPORTEDLY, THE BALLOON ALLEGEDLY CRACKED AND LEAKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976712 ↗
• MalfunctionMar 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE UNDER THE RIGHT FOREARM ENDOVASCULAR FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED AT LESS THAN 15 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957535 ↗
• MalfunctionMar 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT FOREARM ENDOVASCULAR FISTULA, DURING THE PRESSURIZATION PROCESS, AIR LEAKAGE WAS ALLEGEDLY FOUND, AND THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE LEAKING WHEN REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939148 ↗
• MalfunctionMar 13, 2024Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT UPPER LIMB, THE PTA BALLOON ALLEGEDLY RUPTURED AT 26 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892540 ↗
• MalfunctionFeb 26, 2024Peeled/Delaminated; Material Rupture; Unraveled Material; Peeled/Delaminated; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 18ATM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775214 ↗
• MalfunctionFeb 23, 2024Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE VENOUS OUTFLOW TRACT THROUGH THE DISTAL RADIAL ARTERY APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED WHEN THE FIRST PRESSURE WAS EXPANDED AND THE AIR PRESSURE PUMP WAS PRESSURIZED TO ABOUT 28 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773888 ↗
• MalfunctionFeb 23, 2024Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT FOREARM, AFTER THE FIRST EXPANSION WHEN THE PRESSURE PUMP WAS PRESSURIZED TO 30 ATM, THE PTA BALLOON CONTRAST ALLEGEDLY LEAKED AND CANNOT BE EXPANDED NORMALLY. IT WAS FURTHER REPORTED THAT THE HEAD OF THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE RUPTURED AFTER 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 18769133 ↗
• MalfunctionDec 21, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 26 ATM. IT WAS FURTHER REPORTED THAT THE SHEATH WAS REMOVED AT THE SAME TIME AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371681 ↗
• MalfunctionDec 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301088 ↗