Conquest® CQ75104Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741063220), received between Jan 24, 2017 and Sep 29, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (12 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Rupture

  On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (PTA) procedure under digital subtraction angiography (DSA) guidance using a Conquest balloon catheter. During the procedure, after the balloon catheter was advanced to the target lesion site, inflation was initiated using a pressure inflation device. However, the inflation device suddenly lost pressure and rapidly deflated. Multiple attempts were made to re-establish pressure; however, the system failed to maintain inflation. Upon evaluation, a cannula-like rupture of the balloon was identified at approximately 10 atm. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930843 ↗
• MalfunctionApr 29, 2026Difficult to Remove; Device-Device Incompatibility

  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 UNABLE TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25025568 ↗
• MalfunctionMar 5, 2026Difficult to Remove; Unraveled Material; Difficult to Open or Remove Packaging Material

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SHEATH WAS ALLEGEDLY STUCK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517544 ↗
• MalfunctionJul 24, 2025Stretched; Failure to Advance; Device-Device Incompatibility; Stretched; Failure to Advance; Device-Device Incompatibility

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE WIRE ALLEGEDLY CANNOT ENTER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585362 ↗
• MalfunctionDec 12, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TAIL OF THE BALLOON WAS ALLEGEDLY RUPTURED AT 30 ATM. IT WAS FURTHER REPORTED THAT THE CONTRAST MEDIUM WAS LEAKED UNDER THE CONTRAST. REPORTEDLY, THE PRESSURE PUMP COULD NOT BE PULLED BACK. FURTHERMORE, THE BALLOON WAS PULLED OUT VIGOROUSLY AND THERE WAS DIFFICULTY IN RETRIEVING THE BALLOON VIA THE CATHETER SHEATH AFTER THE BALLOON RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911910 ↗
• MalfunctionOct 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA ULTRASOUND-GUIDED REPEATED TWISTING OF THE GUIDEWIRE TO PASS THE GUIDEWIRE THROUGH THE FOREARM CEPHALIC VEIN VALVULAR LESION USING A BALLOON, THE BALLOON ALLEGEDLY RUPTURED AT 20ATM. REPORTEDLY, THE BALLOON WAS PULLED OUT OF THE SHEATH, AFTER THE BALLOON CAME OUT A SMALL HOLE WAS FOUND ON THE SIDE OF THE PROXIMAL TIP. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520986 ↗
• MalfunctionDec 15, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING A LEFT UPPER LIMB VENOUS BALLOON DILATION ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333523 ↗
• MalfunctionJan 23, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE CORNER OF BOX WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223284 ↗
• MalfunctionNov 8, 2022Deflation Problem; Inflation Problem; Material Deformation; Deflation Problem; Inflation Problem; Material Deformation

  IT WAS REPORT THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INFLATION PROBLEM. IT WAS FURTHER REPORTED THAT BALLOON ALLEGEDLY RECOILED VERY SLOWLY DURING THE DEFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757379 ↗
• MalfunctionAug 13, 2022Deflation Problem; Inflation Problem; Difficult to Open or Remove Packaging Material; Deflation Problem; Inflation Problem; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY CANNOT REACH THE DESIRED PRESSURE DURING THE INFLATION. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD DEFLATION PROBLEM. REPORTEDLY, THE REMOVAL OF THE BALLOON PROTECTOR WAS QUITE TIGHT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222529 ↗
• MalfunctionMar 8, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE LEFT UPPER ARM FISTULA, THE BALLOON ALLEGEDLY DID NOT INFLATE COMPLETELY. THE DEVICE WAS REMOVED AND WAS NOTED TO INFLATE OUTSIDE THE PATIENT HOWEVER, WAS UNABLE TO BE DEFLATED EASILY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691946 ↗
• MalfunctionDec 31, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DEFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN USED PERCUTANEOUS PUNCTURE DIRECTLY ON THE BALLOON AND REMOVED THE WHOLE DEVICE SYSTEM FROM PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13123349 ↗
• MalfunctionAug 15, 2021Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component; Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE STERILE PACKAGING WAS FOUND TO BE ABSENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322342 ↗
• MalfunctionJun 17, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12015125 ↗
• MalfunctionJun 7, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT POST PROCEDURE, THE BALLOON HAD A DEFLATION PROBLEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946711 ↗
• MalfunctionJun 7, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT POST PROCEDURE, THE BALLOON HAD A DEFLATION PROBLEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946709 ↗
• MalfunctionMay 5, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE THE BALLOON ALLEGEDLY FAILED TO DEFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775637 ↗
• InjuryMar 29, 2021Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED MORE MEDICATION TO REMAIN SEDATED. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11580609 ↗
• MalfunctionMar 18, 2021Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ARM BRACHIAL VEIN STENOSIS, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY HAD RETRACTION ISSUE THROUGH THE SHEATH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11512530 ↗
• MalfunctionJan 12, 2021Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH LEFT BRACHIAL DRAINAGE VEIN, THE PTA BALLOON OUTER LAYER ALLEGEDLY UNRAVELED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154366 ↗
• MalfunctionOct 26, 2020Burst Container or Vessel; Fracture; Material Rupture; Burst Container or Vessel; Fracture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND BURST CONTAINER OR VESSEL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE 58 YEAR OLD MALE PATIENT AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737570 ↗
• MalfunctionOct 26, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75104 BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737554 ↗
• MalfunctionJul 16, 2020Break; Inflation Problem; Material Twisted/Bent; Break; Inflation Problem; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED INFLATION PROBLEM, BREAK AND MATERIAL TWISTED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286849 ↗
• MalfunctionJan 15, 2020Break; Unraveled Material; Break; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593573 ↗
• MalfunctionOct 16, 2019Peeled/Delaminated; Material Rupture; Unraveled Material; Peeled/Delaminated; Material Rupture; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED PEELED LAYER, MATERIAL RUPTURE, AND UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197781 ↗