Check-Flo G10025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002100251), received between Oct 3, 2016 and Dec 13, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2018Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160772 ↗
• MalfunctionJul 11, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, DURING A TRANS FEMORAL ARTERY TUMOR EMBOLIZATION PROCEDURE, THE PROXIMAL END OF TWO NEEDLES FROM TWO PERFORMER INTRODUCERS BENT. DURING THE PROCESS OF PUNCTURING THE ACCESS SITE, THE FIRST NEEDLE BENT AT THE PROXIMAL END. A SECOND COMPLAINT DEVICE WAS UTILIZED WHICH ALSO BENT AT THE PROXIMAL END WHILE PUNCTURING THE SITE. FINALLY, A THIRD PERFORMER INTRODUCER NEEDLE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE COMPLAINANT, ADDITIONAL INFORMATION IS NOT AVAILABLE FROM THE FACILITY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S ANATOMY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE NOR WERE ANY ADDITIONAL PROCEDURES REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7677905 ↗
• MalfunctionOct 3, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE CONNECTION BETWEEN THE VALVE AND INTRODUCER LEAKED BLOOD. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5993378 ↗