Conquest® 40 CQF5064Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741060151), received between Jul 16, 2020 and Jul 15, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Difficult to Remove; Failure to Advance; Device-Device Incompatibility

  ON (B)(6) 2025, A 60-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 PTA BALLOON CATHETER FOR CEPHALIC VEIN FISTULA. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY CANNOT REWIRE. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN RETRACTING THE BALLOON THRU THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505572 ↗
• MalfunctionApr 11, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21823856 ↗
• MalfunctionJan 31, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THERE WAS LEAKAGE AT THE Y-CONNECTION DURING BALLOON PRESSURIZATION. REPORTEDLY, THE Y BASE OF THE CATHETER WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280747 ↗
• MalfunctionApr 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PROXIMAL TIP OF THE PTA BALLOON ALLEGEDLY HAD A CRACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822795 ↗
• MalfunctionJul 16, 2020Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF5064 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED PINHOLE RUPTURE AND PEELED PEBAX. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286882 ↗