Conquest® 40 CQF7594Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741060601), received between Apr 12, 2019 and Sep 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  On (b)(6) 2026, a 64-year-old male patient was prepared for a percutaneous transluminal angioplasty (PTA) procedure using a Conquest 40 balloon catheter via a right arm arteriovenous fistula. Prior to patient use, during device preparation, the Conquest balloon catheter was advanced through the sheath; however, the balloon failed to inflate, and fluid leakage was observed from the hub due to a crack. It was further reported that a complete fracture of the balloon catheter was identified. The device was not used on the patient. The procedure was subsequently completed using another balloon catheter, resulting in a procedural delay. There was no reported patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927852 ↗
• MalfunctionFeb 23, 2023Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED WITHIN NOMINAL BURST PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16426291 ↗
• MalfunctionJul 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT BRACHIOCEPHALIC FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14942576 ↗
• MalfunctionOct 19, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE AND FAILED TO DEFLATE. A GAUGE NEEDLE AND FLUOROSCOPY GUIDANCE WERE USED TO GENTLY RUPTURE THE BALLOON AND DISPERSE CONTRAST TO ALLOW BALLOON TO DEFLATE. THE PATIENT WAS HEMODYNAMICALLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12653249 ↗
• MalfunctionJun 29, 2021Material Frayed; Difficult to Remove; Material Rupture; Unraveled Material; Material Frayed; Difficult to Remove; Material Rupture; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082303 ↗
• MalfunctionMar 25, 2021Inflation Problem; Peeled/Delaminated; Inflation Problem; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE AXILLARY VEIN, THE BALLOON ALLEGEDLY WOULD NOT INFLATE. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566910 ↗
• MalfunctionFeb 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH FEMORAL IN THE AVF, THE PTA BALLOON ALLEGEDLY RUPTURED AT 19 ATM IN STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11383337 ↗
• MalfunctionFeb 5, 2021Burst Container or Vessel; Material Rupture; Burst Container or Vessel; 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 11284698 ↗
• MalfunctionFeb 2, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 19 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11264534 ↗
• MalfunctionOct 16, 2019Burst Container or Vessel; Burst Container or Vessel

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BURST. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198589 ↗
• MalfunctionApr 12, 2019Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUES DURING AN ANGIOPLASTY IN A FISTULA. IT WAS FURTHER REPORTED THAT THE CATHETER SHAFT OF THE PTA BALLOON ALLEGEDLY BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE MALE PATIENT, 36 YEARS OF AGE AND THE WEIGHT WAS NOT PROVIDED. THIS PATIENT HAD NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510239 ↗