Check-Flo G07600Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002076006), received between Apr 24, 2018 and Apr 24, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A VENOGRAPHY, APPROXIMATELY 2 CENTIMETERS (CM) OF THE 10 (B)(4) PERFORMER INTRODUCER BROKE OFF AND WAS RETAINED IN THE PATIENT. THE PIECE WAS NOT FOUND. ACCESS WAS GAINED VIA THE LEFT GROIN USING AN IPSALATERAL APPROACH. THERE WAS NO PROBLEM WITH INSERTION, NO CALCIFICATION OR TORTUOSITY; HOWEVER, THE VEINS WERE NARROWED AND COMPRESSED. THE 10FR PERFORMER INTRODUCER WAS REMOVED AND THE INCISION WAS ENLARGED TO ACCOMMODATE A LARGER 16FR PERFORMER INTRODUCER WHICH WAS INSERTED TO DEPLOY A "Z STENT." THE PHYSICIAN DENIES ACCIDENTALLY CUTTING THE 10FR INTRODUCER. AFTER COMPLETION OF THE STENT DEPLOYMENT, THE 16FR PERFORMER INTRODUCER WAS REMOVED. THE 10FR PERFORMER INTRODUCER WAS RE-INSERTED IN ORDER TO FINISH THE PROCEDURE. IT WAS AT THAT TIME THE INTRODUCER WAS NOTED TO BE BROKEN. OVERALL, IT WAS REPORTED THAT THE VENOPLASTY AND STENT DEPLOYMENT WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE INITIAL REPORTER, THERE ARE NO PLANS TO ATTEMPT TO REMOVE THE FOREIGN BODY. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7454663 ↗