Flexor G56226Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002562264), received between Mar 23, 2016 and Nov 14, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Crack; Unraveled Material; Crack; Unraveled Material

  AS REPORTED, UPON INSERTION OF THE DEVICE DURING AN UNKNOWN PROCEDURE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH LEAKED BLOOD FROM A CRACK IN THE HUB. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED, DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. PER THE REPORTER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689010 ↗
• MalfunctionNov 8, 2018Stretched; Deformation Due to Compressive Stress; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH STRETCHED DURING AN AORTOGRAM WITH RUNOFF PROCEDURE (REFER TO THIS REPORT). ADDITIONALLY, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER INFLATED WITH AN UNSPECIFIED MIXTURE OF SALINE TO CONTRAST, RUPTURED (REFER TO REPORT REFERENCE NUMBER 1820334-2018-03188). ACCORDING TO THE INITIAL REPORTER, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS INSERTED IN THE COMMON FEMORAL ARTERY, CONTRALATERALLY AND UP-AND-OVER. THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS PLACED BELOW THE KNEE (BK) IN THE TIBIAL VESSEL. IT WAS REPORTED, THE BALLOON DEVICE WAS INFLATED IN THE PATIENT'S SOMEWHAT TORTUOUS ANATOMY, AND BURST BEFORE REACHING RATED BURST PRESSURE. IT IS UNKNOWN WHETHER THE PATIENT'S ANATOMY WAS CALCIFIED, AS THE PHYSICIAN COULDN'T RECALL SPECIFICS OF THE INCIDENT WHEN THE AREA REPRESENTATIVE FOLLOWED UP IN ATTEMPT TO GET MORE DETAILS. THE RUPTURED ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS REMOVED OVER AN UNSPECIFIED WIRE GUIDE WITHOUT ISSUE, AND REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS THE PROCEDURE WAS FINISHING UP, THE PHYSICIAN EXPERIENCED SOME DIFFICULTY REMOVING THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH FRO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053369 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. REFER TO H10 FOR INVESTIGATION FINDINGS.

  Patient problems: Reaction

  MAUDE report 7686676 ↗
• MalfunctionMay 16, 2017Difficult to Insert; Material Deformation

  PRIOR TO PATIENT CONTACT, THE COMPLAINANT DISCOVERED THAT THE DISTAL TIP OF THE INTRODUCER WAS DEFORMED. THE COMPLAINANT ALSO NOTED THAT THE WIRE GUIDE COULD NOT BE INSERTED DURING SHEATH EXCHANGE AND THAT THE SHEATH HAD CONTACT WITH THE PUNCTURE SITE, BUT NOT WITH PATIENT ITSELF. UPON FURTHER REVIEW OF THE DEVICE, IT WAS NOTED THAT THE DISTAL EDGED OF THE SHEATH WAS CURLED IRREGULARLY AND DID NOT DISPLAY A SMOOTH TRANSITION TO THE DILATOR. HOWEVER, NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6570452 ↗
• InjuryMar 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A WIRE EXCHANGE WAS USED TO PLACE A 6FR FLEXOR CHECK-FLO INTRODUCER WITH MINIMAL RESISTANCE; HOWEVER IT WAS UNABLE TO BE PASSED BEYOND THE DISTAL ABDOMINAL AORTA. THE 6FR CHECK-FLO INTRODUCER WAS REMOVED HOWEVER THE INTRODUCER UNRAVELED DURING REMOVAL AND A HEMORRHAGE FROM THE FEMORAL ARTERY WAS NOTED. A PORTION OF THE PATIENT'S FEMORAL ARTERY WAS LACERATED AND THE INTIMAL LINING OF THE PATIENT'S FEMORAL ARTERY WAS NOTED ON THE DEVICE UPON REMOVAL. NO SECTION REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH SMALL INTRODUCER WITHOUT FURTHER INCIDENT. DUE TO THE LACERATION AND PROFUSE HEMORRHAGING, THE PATIENT BECAME HYPOTENSIVE AND UNSTABLE. DURING CLOSURE, DEEPER DISSECTION WAS REQUIRED TO RETRIEVE THE LACERATED FEMORAL ARTERY RESULTING IN POSSIBLE DAMAGE TO THE FEMORAL NERVE. COMPLICATIONS LED TO A NEED FOR A LARGER INCISION THAN INTENDED, INCREASED SURGICAL TIME, PROLONGED RECOVERY TIME, AND EXTREME DISCOMFORT UPON RECOVERY. THIS REPORT IS BEING SUBMITTED AS A CAUTIONARY MEAN, AS THE DEVICE IS NOT INTENDED TO BE USED ON CANINES.

  Patient problems: Laceration(s); No Code Available

  MAUDE report 5519310 ↗