Ascend AQ G32840Recalls & reported problems
Cook Incorporated · Ascend, AQ, Ureteral Dilation Balloon Catheter Set · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002328402), received between Dec 30, 2014 and Apr 14, 2016 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Balloon burst” (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
Device problems
- Balloon burst1
- Material Rupture1
Patient problems
- No Known Impact Or Consequence To Patient1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2016Material Rupture; Material Rupture
DURING THE PROCEDURE, THE BALLOON RUPTURED IN THE PATIENT'S URETER. ACCORDING TO THE REPORTER, NO PORTION OF THE COMPLAINT DEVICE REMAINS INSIDE THE PATIENT. THIS BALLOON WAS REMOVED AND THE PHYSICIAN PLACED A STENT TO COMPLETE THE INTENDED PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5576001 ↗InjuryDec 30, 2014Balloon burst
ASCEND URETERAL DILATION BALLOON CATHETER BURST AFTER BEING INFLATED TO 12 ATM IN THE PATIENT'S URETER. THE BALLOON WAS REMOVED OVER THE GUIDEWIRE AND A CYSTOGRAM WAS PERFORMED NUMEROUS TIMES. SOME MINOR PERFORATION WAS NOTED AT THE DISTAL POSTERIOR TIP OF THE URETER. INSTEAD OF THE STENT BEING PLACED AFTER, A FOLEY CATHETER WAS INSERTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. SOME MINOR PERFORATION WAS NOTED AT THE DISTAL POSTERIOR TIP OF THE URETER. INSTEAD OF THE STENT BEING PLACED AFTER, A FOLEY CATHETER WAS INSERTED. A CYSTOGRAM WAS PERFORMED.
Patient problems: Perforation
MAUDE report 4381433 ↗
Other DILATOR, CATHETER, URETERAL devices
- Porges Coloplast RBD014Coloplast A/S · DILATOR, CATHETER, URETERAL1 recall0 reports
- Bard® X-Force® Balloon Dilation Catheter 998706C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL38 reports
- Bard® X-Force® Balloon Dilation Catheter 998606C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL27 reports
- Bard® X-Force® Balloon Dilation Catheter 998006C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL25 reports
- Bard® X-Force® Balloon Dilation Catheter 998806C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL23 reports
- Bard® X-Force® Balloon Dilation Catheter 998504C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL16 reports
- Passport M0062181100Boston Scientific Corporation · DILATOR, CATHETER, URETERAL15 reports
- Bard® X-Force® Balloon Dilation Catheter 998004C. R. Bard, Inc. · DILATOR, CATHETER, URETERAL15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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