Conquest® CQ7582Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741063091), received between Mar 24, 2017 and Jan 16, 2020 — classified as 5 malfunctions.

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

• MalfunctionJan 16, 2020Break; Break

  THIS REPORT SUMMARIZES TWO MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7582 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE PATIENT WITH NO PATIENT CONTACT. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS MALE, AND THE WEIGHT IS (B)(6) LBS.

  Patient problems: No Patient Involvement

  MAUDE report 9596207 ↗
• MalfunctionJan 16, 2020Break; Break

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATED THAT MODEL CQ7584, PTA DILATATION CATHETER, ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT. THE PATIENT WAS A (B)(6) YEAR-OLD MALE WEIGHING (B)(6) LB.

  Patient problems: No Patient Involvement

  MAUDE report 9596003 ↗
• MalfunctionJan 15, 2020Break; Leak/Splash; Break; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7582 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD MALE PATIENT WAS (B)(6) LB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593809 ↗
• MalfunctionNov 28, 2017Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY OF A CEPHALIC VEIN FISTULA, AN ALLEGED BREAK OCCURRED IN THE CATHETER SHAFT. UPON REMOVAL FROM THE PATIENT THE CATHETER SHAFT ALLEGEDLY BROKE IN A DIFFERENT LOCATION. THE BALLOON, GUIDEWIRE, AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. IT WAS FURTHER REPORTED THAT A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7063868 ↗
• MalfunctionMar 24, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT PULMONARY ARTERY FOR STENOSIS, THE PTA BALLOON WAS INFLATED TWICE TO 20 ATMS AND WOULD NOT DEFLATE AFTER THE SECOND INFLATION. EXTERNAL PRESSURE WAS APPLIED TO DEFLATE THE BALLOON AND THE CATHETER WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6432916 ↗