Conquest® CQ7568Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741062919), received between Jun 20, 2018 and May 14, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (5 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.

• MalfunctionMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 10 ATM AT THE FIRST DILATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307439 ↗
• MalfunctionNov 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 12ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910273 ↗
• MalfunctionJul 16, 2020Inflation Problem; Peeled/Delaminated; Material Rupture; Inflation Problem; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7568 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED PINHOLE BALLOON RUPTURE AND HAD INFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. THE PATIENT WAS REPORTED TO BE A (B)(6) YEAR OLD FEMALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286847 ↗
• MalfunctionJul 16, 2020Material Frayed; Material Frayed

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CQ7568 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL FRAYED. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286349 ↗
• MalfunctionApr 15, 2020Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7568 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM AND RETRACTION PROBLEM. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965563 ↗
• MalfunctionDec 13, 2018Material Frayed; Peeled/Delaminated; Material Rupture; Material Frayed; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162596 ↗
• MalfunctionJun 21, 2018Material Frayed; Peeled/Delaminated; Unraveled Material; Material Frayed; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RADIAL ARTERY, UPON REMOVING THE PTA BALLOON FROM THE PATIENT, UNRAVELED MATERIAL WAS ALLEGEDLY FOUND. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7627141 ↗
• MalfunctionJun 20, 2018Material Frayed; Peeled/Delaminated; Unraveled Material; Material Frayed; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RADIAL ARTERY, UPON REMOVING THE PTA BALLOON FROM THE PATIENT, UNRAVELED MATERIAL WAS FOUND. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7623519 ↗
• MalfunctionJun 20, 2018Material Frayed; Peeled/Delaminated; Unraveled Material; Material Frayed; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RADIAL ARTERY, UPON REMOVING THE PTA BALLOON FROM THE PATIENT, UNRAVELED MATERIAL WAS FOUND. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7623515 ↗