Flexor G56233Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002562332), received between May 26, 2017 and May 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE BELOW-THE-KNEE AND WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE HUB OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED FROM THE DEVICE. CONTRALATERAL ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE VESSELS WERE REPORTEDLY CALCIFIED. ANOTHER MANUFACTURER¿S STENTS WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. AS THE SHEATH WAS PULLED BACK BY THE HUB, OVER ANOTHER MANUFACTURER¿S 0.035-INCH WIRE GUIDE, TO FACILITATE PLACEMENT OF A STENT IN THE MORE PROXIMAL SFA ON THE CONTRALATERAL SIDE, THE HUB SEPARATED, RESULTING IN BLOOD LOSS. THE SEPARATED SHAFT WAS MANUALLY REMOVED FROM THE PATIENT. AFTER SUCCESSFUL REMOVAL OF THE SHEATH, A NEW SHEATH WAS ADVANCED OVER THE WIRE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22105487 ↗
• MalfunctionJun 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210059 ↗
• MalfunctionJul 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HEMOSTATIC VALVE OF TWO FLEXOR HIGH-FLEX ANSEL GUIDING SHEATHS SEPARATED FROM THE DEVICES DURING AN ENDOVASCULAR ANEURYSM REPAIR. ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY TO TARGET THE SUPERIOR MESENTERIC ARTERY. EACH DEVICE WAS USED OVER A GLIDE WIRE. DURING REMOVAL OF EACH DEVICE, THE HEMOSTATIC VALVE SEPARATED FROM THE DEVICE. THE DEVICES WERE PULLED BY THE HUB DURING REMOVAL. THE DILATOR WAS IN PLACE DURING REMOVAL AND SEPARATION OF EACH DEVICE. A THIRD DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214147 ↗
• MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS AVAILABLE AND INADVERTENTLY OMITTED FROM THE INITIAL REPORT. RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF THE DEVICE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH, AND WAS NOT IN PLACE AT THE TIME OF HUB SEPARATION. BLOOD LOSS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821912 ↗
• MalfunctionNov 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10842606 ↗
• MalfunctionAug 15, 2019Material Separation; Material Separation

  NO 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 8896718 ↗
• MalfunctionMay 26, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LOWER EXTREMITY AGRAM WITH ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, THE HUB SEPARATED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN WENT TO REMOVE THE 8F ANSEL SHEATH FROM THE PTS RIGHT GROIN. HE PULLED FROM THE CHECK FLO HUB WITH MINIMAL FORCE AND THE HUB SEPARATED CLEAN FROM THE BODY OF THE INTRODUCER, EXPOSING THE FLARED END OF THE 8F INTRODUCER. THE PHYSICIAN WAS STILL ABLE TO SAFELY REMOVE THE SHEATH FROM THE PATIENT WITHOUT ISSUE. NO ADDITIONAL PROCEDURES WERE REQUIRED. IT WAS REPORTED THAT THE PATIENT'S TISSUE WAS SCARRED AND THE PHYSICIAN DID NOT RE-INTRODUCE THE SHEATH'S INNER DILATOR PRIOR TO REMOVING. THE PATIENT WAS NOT HARMED IN ANY WAY AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593883 ↗