Conquest® CQ7562Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741062896), received between May 17, 2018 and Apr 19, 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 19, 2019Material Frayed; Peeled/Delaminated; Material Frayed; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ7562 CONQUEST PTA BALLOON DILATATION CATHETER EXPERIENCED FRAYING AND PEELING. THE EVENT DID INVOLVE THE PATIENT BUT THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) KGS. THE CQ7584 CONQUEST PTA BALLOON DILATATION CATHETER WAS NOT RETURNED TO THE MANUFACTURER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533553 ↗
• MalfunctionApr 12, 2019Peeled/Delaminated; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ7562 PTA BALLOON DILATATION CATHETER ALLEGEDLY HAD PEELED MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED INSIDE THE PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511920 ↗
• MalfunctionJun 14, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ARM, UPON REMOVING THE PTA BALLOON FROM THE PATIENT, UNRAVELED MATERIAL WAS FOUND ON THE PTA BALLOON. THE HEALTH CARE PROVIDER USED ANOTHER PTA BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602153 ↗
• MalfunctionMay 17, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE BALLOON FIBERS ALLEGEDLY UNRAVELED UPON REMOVING FROM THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7523936 ↗