Cook G15540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002155404), received between May 23, 2016 and Mar 3, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE URODYNAMICS BALLOON CATHETER BROKE UPON INFLATION. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823642 ↗
• InjuryMay 23, 2016Material Rupture; Material Rupture

  DURING A CYSTOMETRY AND URETHRAL PRESSURE PROFILOMETRY PROCEDURE. THE BALLOON BROKE (RUPTURED) WHILE WITHIN THE PATIENT. THERE IS CONCERN THAT THERE MAY BE SOME FRAGMENTS LEFT INSIDE PATIENT. IT IS UNKNOWN IF THERE HAVE BEEN ANY ADVERSE EFFECTS AT THIS TIME OR THE CONDITION OF THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED AS THE INDIVIDUAL WHO ORIGINALLY REPORTED THE INCIDENT HAS SINCE RETIRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 5673412 ↗