Conquest® 40 CQF75104Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741060632), received between Nov 22, 2016 and Jul 7, 2025 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Packaging Problem; Packaging Problem

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE ITEM ARRIVED DAMAGED AND BENT. IT WAS FURTHER REPORTED THAT THE OUTER AND INNER BOXES WERE DAMAGED DURING SHIPPING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409544 ↗
• MalfunctionJul 7, 2025Packaging Problem; Packaging Problem

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE ITEM ARRIVED DAMAGED AND BENT. IT WAS FURTHER REPORTED THAT THE OUTER AND INNER BOXES WERE DAMAGED DURING SHIPPING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409541 ↗
• MalfunctionApr 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PRESSURE COULD NOT BE INCREASED BEYOND 30 AND THE PTA BALLOON ALLEGEDLY BURST, WHEN IT WAS BEING RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21812361 ↗
• MalfunctionMar 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 32 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581357 ↗
• MalfunctionNov 2, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20594282 ↗
• MalfunctionMay 17, 2024Deflation 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 NEVER FULLY INFLATED EVEN USING 30 ATM ON THE INDEFLATOR. IT WAS FURTHER REPORTED THAT THE BALLOON HOWEVER DID INFLATED JUST SLIGHTLY BUT ALLEGEDLY WOULD NOT DEFLATE ALL THE WAY. FURTHERMORE, THERE WAS SLIGHT DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE SHEATH AS SOME FLUID WAS STILL IN THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342526 ↗
• MalfunctionMar 19, 2024Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULDN'T COME OUT OF THE TUBING, AND IT GOT SNAPPED ON THE BLACK PORTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928487 ↗
• MalfunctionJan 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BLACK TIP ALLEGEDLY BROKE OFF OF THE BALLOON WHEN TRIED TO RE-SHEATH THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605858 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LEFT FISTULA, THE PTA BALLOON ALLEGEDLY HAD HOLES IN THE UPPER ONE THIRD AND LOWER TWO THIRD AT FIRST INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314163 ↗
• MalfunctionJun 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PERIPHERAL DIALYSIS FISTULA VIA LEFT ELBOW, 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 17037477 ↗
• MalfunctionMar 14, 2023Difficult to Remove; Material Rupture; Unraveled Material; Difficult to Remove; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR MID CEPHALIC VEIN LESION, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT WHEN THE BALLOON WAS ATTEMPTED TO REMOVE FROM THE PATIENT, THE BALLOON BECAME STUCK IN THE SHEATH. REPORTEDLY, THE BALLOON AND SHEATH WERE REMOVED AS ONE OVER THE WIRE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535754 ↗
• InjuryDec 26, 2022Entrapment of Device; Material Rupture; Detachment of Device or Device Component; Entrapment of Device; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DETACHED INTO SEGMENTS AND WERE LEFT IN THE PORTAL VEIN. FURTHER, THE BALLOON ADHERED TO THE VESSEL WITH A GORE STENT TO PREVENT IT FROM MIGRATING. REPORTEDLY, THE DEVICE WAS DIFFICULT TO RETRIEVE FROM THE PATIENT WHICH REQUIRED ADDITIONAL INTERVENTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16046587 ↗
• MalfunctionMay 24, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS PUNCTURED SUBCUTANEOUSLY WITH NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487126 ↗
• MalfunctionDec 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PTA PROCEDURE, THE DEVICE ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13032237 ↗
• MalfunctionAug 28, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381189 ↗
• MalfunctionJul 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 4 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178988 ↗
• MalfunctionMay 25, 2021Material 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 11875316 ↗
• MalfunctionMay 5, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776837 ↗
• MalfunctionApr 22, 2021Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11705073 ↗
• MalfunctionApr 12, 2021Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647729 ↗
• InjuryMar 1, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, PTA BALLOON ALLEGEDLY FAILED TO DEFLATE AFTER THE FIRST INFLATION. IT WAS FURTHER REPORTED THAT GAUGE ACCESS NEEDLE WAS USED TO PUNCTURE AND DEFLATE BALLOON. THE PATIENT CURRENT STATUS WAS STABLE.

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

  MAUDE report 11395241 ↗
• MalfunctionDec 10, 2020Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10982770 ↗
• MalfunctionNov 17, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED IN SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10849827 ↗
• MalfunctionOct 26, 2020Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CQF75104 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM AND INFLATION PROBLEM. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE (B)(6) YEAR OLD FEMALE PATIENT WEIGHED (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734776 ↗
• MalfunctionOct 16, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF75104, PTA DILATATION CATHETER, ALLEGEDLY EXPERIENCED A BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENT IS MALE, 77 YEARS OLD, AND 165 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198664 ↗