Flexor G56227Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002562271), received between Feb 11, 2019 and Sep 30, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjurySep 30, 2025Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23178473 ↗
• MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A FENESTRATED ENDOVASCULAR DEVICE IMPLANTATION FOR A TYPE 1A ENDOLEAK INVOLVING ANOTHER MANUFACTURER¿S DEVICE THAT HAD BEEN INDWELLING FOR APPROXIMATELY EIGHT YEARS, THE HUB OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED UPON INTRODUCTION OF THE DEVICE. THE FLEXOR SHEATH AND DILATOR WERE INSERTED INTO A RENAL ARTERY OVER A 260-CENTIMETER ROSEN WIRE, THROUGH A LARGE COOK SHEATH, FOR A FENESTRATED PROXIMAL EXTENSION AND RE-LINE OF ANOTHER MANUFACTURER¿S ¿OLD¿ INDWELLING GRAFT. PER THE REPORTER, RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE SHEATH, RESULTING IN THE DEVICE TWISTING DURING ADVANCEMENT. THE ILIAC ARTERIES WERE TORTUOUS, AND THE PRESENCE OF THE INDWELLING GRAFT REPORTEDLY MADE IT DIFFICULT TO TRACK THE SHEATH. PER THE REPORTER, EVERY DEVICE THAT WAS REMOVED THROUGHOUT THE CASE SHOWED SIGNIFICANT DISTORTION FROM THE INDWELLING GRAFT AND THE PATIENT¿S ANATOMY. AFTER THE HUB SEPARATED, THE SHEATH WAS EASILY REMOVED FROM THE PATIENT "IN THE NORMAL MANNER." THERE WERE NO ADDITIONAL COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305416 ↗
• MalfunctionFeb 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8325106 ↗