Conquest® 40 CQF75108Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741060649), received between Jan 22, 2018 and Sep 28, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  On (b)(6) 2026, a patient underwent an angioplasty procedure using a Conquest 40 PTA balloon. During the procedure, the balloon was successfully inflated to dilate a stent. After deflation and withdrawal for repositioning to another treatment site, the physician attempted to reinflate the balloon but observed that it would not maintain pressure. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911163 ↗
• MalfunctionOct 8, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST 40 PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY INVERTED ALONG THE PROXIMAL SEGMENT. IT WAS FURTHER REPORTED THAT IT COULD NOT BE REMOVED FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23244009 ↗
• MalfunctionJul 8, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON MUSHROOMED ON THE DISTAL END AND WAS DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT MANEUVERED THE BALLOON SEVERAL WAYS IN ORDER TO EVENTUALLY REMOVE IT AND RESULTED IN CASE BEING DELAYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434867 ↗
• MalfunctionJun 10, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 PTA BALLOON CATHETER. DURING THE PROCEDURE, WHEN PULLING BACK THE BALLOON RESISTANCE WAS FELT SO IT WAS PULLED WITH MORE FORCE AND BALLOON WAS UNSHEATHED AND STUCK AT THE END OF THE G-TUBE. IT WAS FURTHER REPORTED THAT G-TUBE AND BALLOON REMOVED FROM PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174889 ↗
• MalfunctionJul 9, 2021Inflation Problem; Material Rupture; Material Deformation; Inflation Problem; Material Rupture; Material Deformation

  IT WAS REPORTED DURING A TREATMENT OF STENOSIS IN THE SUPERIOR VENA CAVA JUST BEYOND THE CEPHALIC ARCH, THE BALLOON ALLEGEDLY RUPTURED AT 20 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142599 ↗
• MalfunctionJul 9, 2021Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING A TREATMENT OF STENOSIS IN THE SUPERIOR VENA CAVA JUST BEYOND THE CEPHALIC ARCH, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DEFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142595 ↗
• MalfunctionJul 24, 2019Entrapment of Device; Inflation Problem; Device Contamination with Chemical or Other Material; Entrapment of Device; Inflation Problem; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF75108 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED ENTRAPMENT OF THE DEVICE, INFLATION ISSUES, RETRACTION PROBLEMS, MATERIAL RUPTURE, FAILURE TO ADVANCE AND FOREIGN MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A 71-YEAR-OLD FEMALE WHO WEIGHED 166 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823498 ↗
• MalfunctionJul 16, 2019Break; Material Puncture/Hole; Retraction Problem; Break; Material Puncture/Hole; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF75108 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK, MATERIAL PUNCTURE, AND A RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796346 ↗
• MalfunctionJan 22, 2018Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 ATM. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211383 ↗