S~Curve G32789Recalls & reported problems
Cook Incorporated · S-Curve Urethral Dilator Set With AQ, Hydrophilic Coating · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002327894), received between May 11, 2016 and May 11, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device 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
- Use of Device Problem1
Patient problems
- Perforation1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2016Use of Device Problem; Use of Device Problem
DURING A URETHRAL DILATION PROCEDURE ON THE MALE PATIENT, THE JUNIOR REGISTRAR PLACED THE GUIDE WIRE AND CONFIRMED PLACEMENT VIA "II". HE THEN PLACED THE 12FR AND THE 14FR OVER THE WIRE SEQUENTIALLY. THE 16FR DILATOR WAS THEN USED AND IT PERFORATED THE URETHRA, CAUSING THE SCROTUM TO TAKE ON FLUID AND BECOME ENLARGED. THE CONSULTANT THEN TOOK OVER, CATHETERIZED THE PATIENT FOR THE SWELLING AND TREATED THE PATIENT FOR THE INJURIES CAUSED. NO ADVERSE EFFECT TO THE PATIENT REPORTED. INFORMATION WAS PROVIDED THAT THIS EVENT IS NOT 100% DUE TO A FAULTY PRODUCT AS THE DOCTOR IS VERY JUNIOR AND USER ERROR COULD HAVE COME INTO PLAY.
Patient problems: Perforation; Swelling
MAUDE report 5646181 ↗
Other DILATOR, URETHRAL devices
- Bard® Urologist's Tray 123400C. R. Bard, Inc. · DILATOR, URETHRAL1 recall8 reports
- UroMax Ultra Kit M0062251210Boston Scientific Corporation · DILATOR, URETHRAL1 recall6 reports
- UroMax Ultra Kit M0062251220Boston Scientific Corporation · DILATOR, URETHRAL1 recall5 reports
- UroMax Ultra Kit M0062251370Boston Scientific Corporation · DILATOR, URETHRAL1 recall4 reports
- UroMax Ultra Kit M0062251200Boston Scientific Corporation · DILATOR, URETHRAL1 recall3 reports
- UroMax Ultra Kit M0062251310Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251290Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251240Boston Scientific Corporation · DILATOR, URETHRAL1 recall1 report
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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