Conquest® CQ7564Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741062902), received between Jan 12, 2017 and Jan 12, 2026 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (24 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY GOT RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033472 ↗
• MalfunctionOct 31, 2025Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY REFUSED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS PUNCTURED WITH A NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433570 ↗
• MalfunctionJun 3, 2025Burst Container or Vessel; Burst Container or Vessel

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY NOT BEEN INFLATED. IT WAS FURTHER REPORTED THAT AN ULTRASOUND FOUND THAT THE PUSH ROD WAS DAMAGED, AND AFTER REMOVING IT FROM THE PATIENT'S BODY, IT WAS DETERMINED THAT THE PUSH ROD HAD BURST DURING PRESSURIZATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129564 ↗
• MalfunctionApr 11, 2025Break; Burst Container or Vessel; Break; Burst Container or Vessel

  IT WAS REPORTED THAT DURING AN UPPER LIMB VENOUS BALLOON ANGIOPLASTY PROCEDURE OF THE LEFT ANTERIOR FOREARM, THE PUSH ROD OF THE BALLOON ALLEGEDLY BROKEN. THE BALLOON WAS REMOVED UNDER ULTRASOUND GUIDANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21823091 ↗
• MalfunctionSep 12, 2024Peeled/Delaminated; Material Rupture; Unraveled Material; Material Deformation; Peeled/Delaminated; Material Rupture; Unraveled Material; Material Deformation

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ANGIOPLASTY PROCEDURE IN THE PROXIMAL ANASTOMOTIC STENOSIS VIA THE RIGHT FOREARM OF RADIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 24 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 20208689 ↗
• MalfunctionJul 2, 2024Inflation Problem; Material Rupture; Material Deformation; Inflation Problem; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE UPPER LIMB VEINS OF ARTERIOVENOUS FISTULA ANASTOMOSIS, THE PTA BALLOON WAS USED WITH A DILATATION PRESSURE OF 30 ATM, AND WHEN IT WAS BEING MAINTAINED, THE PRESSURE WAS ALLEGEDLY SUDDENLY RELEASED, AND THE PRESSURE COULD NOT BE GIVEN UP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655500 ↗
• MalfunctionMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE EITHER HAD A HOLE OR ALLEGEDLY BURST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308297 ↗
• MalfunctionFeb 23, 2024Material Rupture; Unraveled Material; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE VENOUS OUTFLOW TRACT, 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 18771033 ↗
• MalfunctionJan 9, 2024Material Frayed; Material Rupture; Material Deformation; Material Frayed; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS FILLED WITH SALINE TO DILATE THE STENOSIS NEAR THE PATIENT'S ANASTOMOSIS AND THE PRESSURE REACHED 30ATM. AFTER THE SECOND TIME, IT BROKE AND WAS SAFELY RECOVERED WITHOUT CAUSING DAMAGE TO THE PATIENT'S BLOOD VESSELS. IT WAS FURTHER REPORTED THAT THE MIDDLE PART OF THE BALLOON WAS RUPTURED. THE OPERATION WAS COMPLETED BY CHANGING THE NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472632 ↗
• MalfunctionJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A LEFT FOREARM FISTULA ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AT 26 ATM WHEN THE PRESSURE WAS APPLIED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433458 ↗
• MalfunctionDec 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ANGIOPLASTY PROCEDURE IN UPPER EXTREMITY VENOUS, THE PTA BALLOON ALLEGEDLY BURST AT 24 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417712 ↗
• MalfunctionDec 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A RIGHT ANTERIOR INTERNAL FISTULA ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED WHEN THE PRESSURE REACHED 25 ATM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382717 ↗
• MalfunctionOct 9, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF THE PTA BALLOON ALLEGEDLY WOULD NOT COME OFF WHEN RETRACTING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894507 ↗
• MalfunctionNov 4, 2022Leak/Splash; Peeled/Delaminated; Material Rupture; Unraveled Material; Leak/Splash; Peeled/Delaminated; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH INTERNAL ARTERIOVENOUS FISTULA OF CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 28 ATM DURING THIRD INFLATION. IT WAS FURTHER REPORTED THAT THE DEVICE AND INTRODUCER SHEATH AS ONE UNIT AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724108 ↗
• MalfunctionNov 2, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON HUB ALLEGEDLY HAD DISLODGED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713165 ↗
• MalfunctionSep 27, 2022Material Frayed; Peeled/Delaminated; Material Rupture; Unraveled Material; Material Frayed; Peeled/Delaminated; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 26 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493139 ↗
• MalfunctionSep 27, 2022Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ULTRASOUND -GUIDED ANGIOPLASTY PROCEDURE, THE PTA BALLOON RUPTURE ALLEGEDLY RUPTURED AT 23 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493058 ↗
• MalfunctionJun 16, 2021Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD FAILED INFLATE AND DEFLATE. IT WAS FURTHER REPORTED THAT THE DEVICE HAD DIFFICULTY IN REMOVING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008608 ↗
• MalfunctionMay 4, 2021Break; Material Rupture; Break; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768381 ↗
• MalfunctionMay 3, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760710 ↗
• MalfunctionNov 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 20 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10842202 ↗
• MalfunctionOct 28, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL CQ7564 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, GENDER AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10752612 ↗
• MalfunctionOct 26, 2020Unraveled Material; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CQ7564 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED UNRAVELED MATERIAL. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734367 ↗
• MalfunctionJul 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CQ7564 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10287373 ↗
• MalfunctionJul 15, 2020Material Rupture; Material Deformation; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7564J PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE (B)(6) YEAR OLD FEMALE PATIENT WEIGHED (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279826 ↗