Conquest® 40 CQF75124Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801741060663), received between May 25, 2018 and Aug 7, 2026 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (30 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170258 ↗
• MalfunctionOct 31, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, 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 BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433749 ↗
• InjuryJan 7, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 26 ATM. IT WAS FURTHER REPORTED THAT THE DOCTOR HAD TO DO A CUT DOWN TO RETRIEVE THE BALLOON. REPORTEDLY, THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. THE CURRENT STATUS OF THE PATIENT IS UNHARMED, PROCEDURE FINISHED AND ACCESS STILL OPEN.

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

  MAUDE report 21089165 ↗
• MalfunctionJan 1, 2025Difficult to Remove; Material Rupture; Packaging Problem; Difficult to Remove; Material Rupture; Packaging Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE BALLOON WAS COMPROMISED IN PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21050968 ↗
• MalfunctionJun 18, 2024Deflation Problem; Entrapment of Device; Deflation Problem; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555589 ↗
• MalfunctionApr 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BURST AT 8 ATM ON THE FIRST 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 19102641 ↗
• MalfunctionAug 2, 2023Material Rupture; Material Deformation; Insufficient Device Problem Information; Material Rupture; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441465 ↗
• MalfunctionApr 24, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CONTRAST WAS ALLEGEDLY LEAKING OUT OF THE TIP OF THE BALLOON FURTHEST 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 16796018 ↗
• MalfunctionMar 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 28 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461253 ↗
• MalfunctionDec 2, 2022Failure to Advance; Device-Device Incompatibility; Device Contamination with Chemical or Other Material; Failure to Advance; Device-Device Incompatibility; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERIOR VENA CAVA, THE PTA BALLOON ALLEGEDLY FAILED TO ADVANCE OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905610 ↗
• MalfunctionNov 8, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15750174 ↗
• MalfunctionOct 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED BEFORE 30 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678564 ↗
• MalfunctionJul 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 12 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14941595 ↗
• MalfunctionMay 20, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP WAS ALLEGEDLY BROKE OFF WHEN TRIED TO TAKE THE BALLOON OUT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY STUCK IN THE SHEATH. REPORTEDLY, THEY WERE NOT ABLE TO RETRIEVE THE TIP OR TAKE THE SHEATH OUT DUE TO CONCERN OVER BLEEDING AND PATIENT WENT TO HOSPITAL TO HAVE IT REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460683 ↗
• MalfunctionFeb 16, 2022Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH RADIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539830 ↗
• MalfunctionDec 16, 2021Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH RADIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015872 ↗
• MalfunctionNov 8, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12766916 ↗
• MalfunctionOct 20, 2021Material Frayed; Material Rupture; Material Frayed; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662910 ↗
• MalfunctionOct 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12630948 ↗
• MalfunctionOct 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12629491 ↗
• MalfunctionOct 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12612005 ↗
• MalfunctionMay 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A VENOPLASTY PROCEDURE IN THE RIGHT UPPER LIMB, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884001 ↗
• MalfunctionMay 26, 2021Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11883000 ↗
• MalfunctionMay 21, 2021Deflation Problem; Inflation Problem; Difficult to Remove; Difficult to Open or Remove Packaging Material; Deflation Problem; Inflation Problem; Difficult to Remove; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE THE BALLOON ALLEGEDLY HAD INFLATION PROBLEM. IT WAS FURTHER REPORTED THAT THE BALLOON HAD DEFLATION PROBLEM AND IT WAS DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861473 ↗
• MalfunctionMay 5, 2021Difficult to Flush; Inflation Problem; Difficult to Flush; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE THROUGH THE LEFT UPPER ARM FISTULA TO TREAT THE SUBCLAVIAN VEIN, THE CATHETER ALLEGEDLY WOULD NOT FILL WITH CONTRAST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775714 ↗