Conquest® 40 CQF7574Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741060496), received between Oct 12, 2016 and Sep 22, 2025 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (38 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.

• MalfunctionSep 22, 2025Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT FORA ANGIOPLASTY PROCEDURE USING CONQUEST 40. PIOR TO AN ANGIOPLASTY PROCEDURE USING THE CONQUEST 40 PTA BALLOON, INNER AND OUTER PACKAGES ALLEGEDLY ARRIVED WET. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23107239 ↗
• MalfunctionSep 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST 40 PTA BALLOON. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING ALLEGEDLY HAVE WATER DAMAGE. IT WAS FURTHER REPORTED THAT THE WATER MARK IS BELOW THE STERILE PACKAGE LINE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037208 ↗
• InjurySep 2, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE UTILIZING THE CONQUEST 40 PTA BALLOON. DURING THIS PROCEDURE, THE BALLOON REPORTEDLY RUPTURED. THE PATIENT IS SAID TO HAVE EXPERIENCED A VESSEL RUPTURE AND SUBSEQUENT BLEEDING. IT HAS BEEN REPORTED THAT ANOTHER BALLOON WAS EMPLOYED TO FINALIZE THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 22931792 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT AROUND 29 OR 30 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018562 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE TIP OF THE PTA BALLOON ALLEGEDLY BROKE OFF WHILE THE BALLOON WAS BEING FLUSHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19368879 ↗
• MalfunctionOct 17, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE FISTULA PUNCTURE AREA, WHEN SUBJECT TO THE FIRST PRESSURIZATION TO 30 ATM, THE PTA BALLOON WAS INFLATED AND ALLEGEDLY GOT FRACTURED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED AND REMOVED DIRECTLY THROUGH SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951961 ↗
• MalfunctionOct 16, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, DURING THE FIRST PRESSURIZATION TO 20 ATM, THE PTA BALLOON WAS ALLEGEDLY NOT INFLATED COMPLETELY. IT WAS FURTHER REPORTED THAT WITH CONTINUOUS PRESSURIZATION, THE PTA BALLOON ALLEGEDLY LEAKED LIQUID. FURTHERMORE, THE BALLOON WAS DEFLATED AND REMOVED DIRECTLY THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17937272 ↗
• MalfunctionOct 13, 2023Deflation Problem; Inflation Problem; Leak/Splash; Deflation Problem; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, DURING THE SECOND INFLATION, THE PTA BALLOON WAS ALLEGEDLY DEFLATED ON ITS OWN WHEN THE PRESSURE WAS INCREASED TO AROUND 35 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED ROTATABLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928683 ↗
• MalfunctionMar 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 16465513 ↗
• MalfunctionSep 13, 2021Difficult to Insert; Difficult to Remove; Material Rupture; Difficult to Insert; Difficult to Remove; Material Rupture

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE AT LEFT BRACHYCEPHALIC FISTULA, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DIFFICULT TO BE 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 12458101 ↗
• MalfunctionJun 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED DURING THE ANGIOPLASTY PROCEDURE AT LEFT BRACHY CEPHALIC FISTULA, THE BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963879 ↗
• MalfunctionJun 8, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE AT LEFT BRACHYCEPHALIC FISTULA, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THE BALLOON WAS ALLEGEDLY DIFFICULT TO BE 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 11953753 ↗
• MalfunctionJan 11, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11145269 ↗
• MalfunctionOct 28, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CQF7574 PTA BALLOON DILATATION CATHETER ALLEGEDLY INFLATION PROBLEM AND MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE 57 YEAR OLD FEMALE PATIENT WAS 50 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10749764 ↗
• MalfunctionOct 26, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7574 PTA 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 10738191 ↗
• MalfunctionOct 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 16 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10726060 ↗
• MalfunctionJul 16, 2020Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CQF7574 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND RETRACTION ISSUE. 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 10286719 ↗
• MalfunctionJan 16, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE MALFUNCTIONS INDICATED THAT MODEL CQF7574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUES. THIS REPORT WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS INVOLVED 4 PATIENTS WITH NO PATIENT CONSEQUENCES. THE FOUR PATIENTS RANGED FROM 58-68 YEARS OF AGE AND WEIGHT RANGE 165-194 LB. OF THE REPORTED PATIENTS 2 WERE MALES AND 2 WERE FEMALE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596757 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CQF7574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT INJURY. THE MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596601 ↗
• MalfunctionOct 16, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BURST AND MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS MALE, (B)(6) YEARS OLD, AND (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198424 ↗
• MalfunctionJul 30, 2019Material Frayed; Material Rupture; Material Deformation; Material Frayed; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES 2 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE 2 RUPTURES, BOTH DID NOT INVOLVE PATIENTS. PATIENT AGE, WEIGHT, AND GENDER WAS NOT PROVIDED FOR EITHER PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8843031 ↗
• MalfunctionJul 22, 2019Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A DEFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) MALE PATIENT WAS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812358 ↗
• MalfunctionJan 7, 2019Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224600 ↗
• MalfunctionJan 7, 2019Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A VENOUS ANASTOMOSIS THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224565 ↗
• MalfunctionJan 7, 2019Deflation Problem; Material Frayed; Material Rupture; Deflation Problem; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A DECLOT THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224442 ↗