Conquest® CQ5062Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741062865), received between Apr 15, 2019 and Dec 12, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913153 ↗
• MalfunctionDec 9, 2023Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR STENOTIC LESION, THE PTA BALLOON 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 18298178 ↗
• MalfunctionNov 24, 2020Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10894788 ↗
• MalfunctionOct 26, 2020Difficult to Insert; Peeled/Delaminated; Unraveled Material; Difficult to Insert; Peeled/Delaminated; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ5062 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DIFFICULT TO INSERT, UNRAVELED MATERIAL AND PEELED/DELAMINATED. 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 IS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737030 ↗
• MalfunctionJul 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ5062 PTA BALLOON DILATATION CATHETER EXPERIENCED A DETACHMENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT. THE PATIENT IS A MALE WEIGHING (B)(6) KGS. PATIENT AGE WAS NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808308 ↗
• MalfunctionApr 15, 2019Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ5062 PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED A RUPTURE . THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WHOSE AGE, WEIGHT AND GENDER WAS NOT PROVIDED. THIS PATIENT HAD NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516329 ↗