Ascend AQ G32838Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002328389), received between Aug 4, 2023 and Aug 4, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2023Material Separation; Material Separation

  AS REPORTED, A PATIENT UNDERWENT A CT SCAN OF THE URINARY TRACT DUE TO PYELONEPHRITIS THAT WAS ACQUIRED AT ANOTHER HOSPITAL. DURING THE CT, A FOREIGN BODY WAS NOTED. THE CAP-SHAPED FOREIGN BODY WAS REMOVED WITH A RIGID URETEROSCOPE. THE PHYSICIAN REVIEWED THE PATIENT'S MEDICAL RECORDS AND DETERMINED APPROXIMATELY 10 YEARS AGO, AT ANOTHER HOSPITAL, THE PATIENT WAS TREATED BY USING A URETERAL STENT (MANUFACTURED BY ANOTHER COMPANY) AND A COOK 'ASCEND® AQ® URETERAL BALLOON CATHETER'. IT IS UNKNOWN EXACTLY WHAT DEVICE THE FOREIGN BODY CAME FROM BUT IS SUSPECTED TO POTENTIALLY BE FROM THE 'ASCEND® AQ® URETERAL BALLOON CATHETER'.

  Patient problems: Foreign Body In Patient

  MAUDE report 17461167 ↗