Check-Flo G15476Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002154766), received between Jun 23, 2016 and Oct 5, 2016 — classified as 4 malfunctions.

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

• MalfunctionOct 5, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT OF UNKNOWN GENDER AND AGE WAS UNDERGOING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE. THE DEVICE WAS BEING PLACED ON THE FLEXIBLE SCOPE AS IRRIGANT SQUIRTED OUT IN THE PHYSICIAN'S FACE. A SECOND DEVICE WAS OPENED AND THE VERY SAME DIFFICULTY OCCURRED. A THIRD ONE WAS OPENED AND USED TO COMPLETED THE INTENDED PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6000054 ↗
• MalfunctionSep 29, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE CHECK-FLO ADAPTER; WHICH WAS ATTACHED TO THE DEVICE, BEGAN TO LEAK. INFORMATION WAS PROVIDED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY AND THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES NOR EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5987208 ↗
• MalfunctionJul 25, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE THE CHECK-FLO ADAPTER LEAKED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 5818679 ↗
• MalfunctionJun 23, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE IS LEAKING INSTEAD OF SELF-SEALING. THE FACILITY IS NOT FOR SURE IF IT'S LEAKING ABOVE OR BELOW THE ADAPTER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5744774 ↗