Ascend AQ G32837Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002328372), received between Sep 9, 2016 and Jul 26, 2017 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PATIENT WAS HAVING A URETEROSCOPY FOR RENAL STONE REMOVAL. THE CUSTOMER ELECTED TO DILATE THE DISTAL URETER OF THE PATIENT WITH A BALLOON AND A G32837-AUBS-5-4 ASCEND® AQ® URETERAL BALLOON CATHETER WAS USED. WHEN THE BALLOON WAS INFLATED UP TO 14 ATM, THE BALLOON BURST AND THE CONTRAST WENT OUT/FLUSHED UP THE URETER. THEY SHOT ADDITIONAL CONTRAST THROUGH THE URETER AND IT SHOWED NO EXTRAVASATION. THEY EXCHANGED FOR A G32834-AUBS-4-4 ASCEND® AQ® URETERAL BALLOON CATHETER, THIS ONE RUPTURED AT 16 ATM OF PRESSURE AND IS REPORTED UNDER REPORT NUMBER 1820334-2017-01805. IT IS UNKNOWN WHAT TYPE OF MEDIUM WAS USED TO INFLATE THE BALLOON. AT THIS TIME, THERE WAS OBVIOUS EXTRAVASATION AND A STENT WAS PUT IN TO LET THE URETER HEAL. THE PATIENT WILL REQUIRE AN ADDITIONAL URETEROSCOPY / RENAL STONE REMOVAL AFTER THE URETER HEALS.

  Patient problems: Extravasation

  MAUDE report 6745323 ↗
• InjurySep 9, 2016Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  VOLUNTARY EVENT REPORT MW5064094 WAS RECEIVED 24AUG2016. INFORMATION WAS PROVIDED THAT THE PHYSICIAN WAS DOING A CYSTOURETHROSCOPY PROCEDURE ON A PATIENT USING A FLEXIBLE URETEROSCOPE. DIFFICULTY WAS EXPERIENCED ADVANCING THE SCOPE SO THE PHYSICIAN ELECTED TO USE A URETERAL BALLOON DILATION. THE PHYSICIAN BEGAN FILLING THE BALLOON WITH CONTRAST MATERIAL AND AT 10 ATM OF PRESSURE, HE SUDDENLY LOST PRESSURE. VULVOSCOPY CONFIRMED THE BALLOON HAD BURST AND THERE WAS EXTRAVASATION OF CONTRAST IN THE AREA. THE BALLOON WAS REMOVED WITH LITTLE DIFFICULTY. UPON REMOVAL, THE DOCTOR EXAMINED THE BALLOON AND FOUND NO EVIDENCE OF PIECES MISSING AND THE BALLOON WAS STILL INTACT. HOWEVER, THERE WAS A CLEAR PERFORATION OF THE BALLOON. AT THIS POINT THE PROCEDURE WAS ABORTED AND DUE TO THE EXTRAVASATION OF CONTRAST, THE DOCTOR ELECTED TO PLACE A URETERAL STENT. ALTHOUGH THE PATIENT DID NOT HAVE AN ADDITIONAL PROCEDURE, A LONGER TERM STENT (10 DAYS VS 3 DAYS) WAS REQUIRED. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME STATED THERE WAS RUPTURE OF THE URETER AS EVIDENCED BY DYE EXTRAVASATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extravasation; No Code Available

  MAUDE report 5938696 ↗