Ascend AQ G32835Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002328358), received between Oct 2, 2017 and Sep 25, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2018Material Integrity Problem; Material Integrity Problem
THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7905101 ↗MalfunctionOct 2, 2017Material Rupture; Material Rupture
AS REPORTED BY THE DISTRIBUTOR, THE ASCEND® AQ® URETERAL BALLOON CATHETER WAS INJECTED WITH ABOUT 2-3 ML OF SALINE SOLUTION THEN THE BALLOON RUPTURED LONGITUDINALLY. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. NO OTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 6908396 ↗
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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