Conquest® CQ5072Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741062940), received between Jun 13, 2018 and Apr 15, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2019Material Frayed; Peeled/Delaminated; Unraveled Material; Material Frayed; Peeled/Delaminated; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ5072 PTA BALLOON DILATATION CATHETER EXPERIENCED FRAYED MATERIAL, A PEELED OUTER LAYER, AND UNRAVELED MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A 61 YEAR OLD MALE, WEIGHING 197 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515481 ↗
• MalfunctionDec 19, 2018Material Frayed; Peeled/Delaminated; Material Rupture; Material Frayed; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT FOREARM, THE PTA BALLOON ALLEGEDLY RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8181760 ↗
• MalfunctionDec 4, 2018Leak/Splash; Peeled/Delaminated; Leak/Splash; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY LEAKED AIR AT 23ATM. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8129991 ↗
• MalfunctionJun 13, 2018Leak/Splash; Peeled/Delaminated; Unraveled Material; Leak/Splash; Peeled/Delaminated; Unraveled Material

  IT WAS ORIGINALLY REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF AN UPPER ARM FISTULA, TWO PTA BALLOONS ALLEGEDLY LEAKED AT 23 ATM. THE PROCEDURE WAS COMPLETED AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597706 ↗