Skip to content

Ascend AQ G32829Recalls & reported problems

Cook Incorporated · Ascend, AQ, Ureteral Dilation Balloon Catheter · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002328297), received between Aug 25, 2017 and Aug 25, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

Device problems

  • Burst Container or Vessel1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionAug 25, 2017Burst Container or Vessel; Burst Container or Vessel

    THE CUSTOMER REPORTED THE ASCEND® AQ® URETERAL BALLOON CATHETER WAS PREPARED TO BE USED IN AN ENDOSCOPIC LITHOTRIPSY URETERAL DILATION FOR EXPANSION OF URETERAL STENOSIS. THE USER FILLED THE BALLOON WITH WATER AND A SMALL AMOUNT OF RESISTANCE WAS MET. THEN THE BALLOON WAS FOUND TO HAVE BROKEN LONGITUDINALLY. THIS OCCURRED PRIOR TO PATIENT CONTACT AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT AND NO IMPACT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

    MAUDE report 6821712 ↗

Other DILATOR, CATHETER, URETERAL devices

All DILATOR, CATHETER, URETERAL devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page