Flexor G56234Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002562349), received between Jan 20, 2017 and Sep 20, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2017Material Separation; Material Separation

  A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS USED IN CARDIAC CATHETERIZATION FOR OCCLUSION OF CORONARY FISTULA UNDER GENERAL ANESTHESIA. IT WAS REPORTED THAT, THE FLEXOR CHECK-FLO INTRODUCER WAS INSERTED INTO THE PATIENT VIA THE PRE-EXISTING 5FR FEMORAL ARTERY SHEATH ALONG A 0.018 PLATINUM PLUS GUIDEWIRE. THE SHEATH POSITION WAS ASSESSED TO BE SATISFACTORY. SOME RESISTANCE WAS NOTED ON TRIAL OF ADVANCING THE VASCULAR PLUG ACROSS THE VALVE OF THE FLEXOR CHECK-FLO INTRODUCER, HENCE THE VALVE WAS PRE-DILATED GENTLY WITH A 5FR DILATOR BEFORE REINTRODUCING THE VASCULAR PLUG. HOWEVER, UPON ADVANCEMENT OF THE VASCULAR PLUG ACROSS THE VALVE, THE SHAFT OF THE FLEXOR CHECK-FLO INTRODUCER WAS NOTED TO HAVE BROKEN OFF FROM THE HUB AND THE SHAFT WAS NOTED TO HAVE EMBOLIZED (WITH THE DISTAL SEGMENT STILL IN THE RIGHT CORONARY FISTULA, A LOOP OF THE INTRODUCER INTO THE LEFT VENTRICLE WHILE THE PROXIMAL END TIP WAS AT THE RIGHT EXTERNAL ILIAC ARTERY). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880268 ↗
• InjuryJan 20, 2017Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED, DURING VASCULAR INTERVENTION OF THE POPLITEAL / TIBIAL ARTERIES, A FLEXOR SHEATH BECAME STUCK INSIDE THE BODY AND A J WIRE WAS UNABLE TO BE PASSED THROUGH THE DEVICE. THE SHEATH WAS RETRIEVED FROM THE PATIENT THROUGH MANIPULATION PERFORMED BY THE PHYSICIAN. ONCE REMOVED, THE SHEATH WAS FOUND TO BE "FLATTENED AND THE LUMEN WAS NOT PATENT." THE PATIENT RETURNED 3 DAYS LATER FOR ANTEGRADE APPROACH TO COMPLETE THE ORIGINAL PROCEDURE. THERE WAS NO REPORTED HARM TO THE PATIENT. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6266041 ↗