Ascend AQ G32834Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002328341), received between Jul 21, 2017 and Jul 19, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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.

• MalfunctionJul 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, PRIOR TO STENT PLACEMENT, THE ASCEND® AQ® URETERAL BALLOON CATHETER WAS TESTED OUTSIDE OF THE PATIENT AND THE BALLOON BURST AT 2 ATMOSPHERES (ATM). THE DEVICE DID NOT MAKE PATIENT CONTACT. AS REPORTED, THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A DIFFERENT, BIGGER STENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703049 ↗
• MalfunctionJul 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE ASCEND AQ URETERAL BALLOON CATHETER WAS USED. AS REPORTED A URETERAL BALLOON DILATOR WAS PLACED OVER THE GUIDEWIRE. THE BALLOON WAS INFLATED AND IT SPONTANEOUSLY RUPTURED. THE BALLOON WAS REMOVED AND EXAMINED. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. NO INJURY NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7684969 ↗
• MalfunctionMar 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED AN ASCEND® AQ® URETERAL BALLOON CATHETER POPPED DURING USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH REGARDS TO THE EVENT AND PATIENT; HOWEVER, NOTHING HAS BEEN MADE AVAILABLE TO DATE. AS REPORTED, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7378211 ↗
• InjuryJul 21, 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. THIS BALLOON IS REPORTED UNDER REPORT NUMBER:1820334-2017-02060. 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 6731729 ↗