Flexor G56231Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00827002562318), received between May 14, 2015 and Sep 30, 2026 — classified as 22 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Material Separation” (34 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946883 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEFT LEG, THE HUB OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY FOR A CONTRALATERAL APPROACH TO A STENOSED DISTAL FEMORAL-TO-POPLITEAL BYPASS. UPON REMOVAL OF THE SHEATH OVER A SUPER-STIFF AMPLATZ WIRE, WITH THE DILATOR IN PLACE, THE HUB SEPARATED FROM THE SHEATH. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24512029 ↗
• InjuryFeb 6, 2026Break

  AS REPORTED, DURING AN ANGIOGRAM, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED INTO TWO SECTIONS. PER THE REPORTER, PRIOR TO THE CASE, A RETROGRADE APPROACH WAS DISCUSSED, AS THE PHYSICIAN ANTICIPATED ENCOUNTERING RESISTANCE; HOWEVER, THE PHYSICIAN ULTIMATELY DECIDED TO USE A CONTRALATERAL APPROACH. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND RESISTANCE WAS ENCOUNTERED AS THE SHEATH WAS ADVANCED AND PARKED JUST ABOVE THE CONTRALATERAL SUPERFICIAL FEMORAL ARTERY (SFA). PER THE REPORTER, THE ACCESS SITE WAS NORMAL; HOWEVER, THE ANATOMY WAS CALCIFIED AND THE VESSELS WERE SMALLER THAN EXPECTED. BILATERAL ILIAC STENTS WERE PRESENT, WHICH REPORTEDLY MAY HAVE CONTRIBUTED TO DIFFICULT TRACKING INITIALLY. THE BIFURCATION WAS "NOT PARTICULARLY" STEEP. A COOK CATHETER AND OTHER MANUFACTURERS¿ BALLOONS WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. REPORTEDLY, ONE OF THE OTHER MANUFACTURERS¿ BALLOONS RUPTURED WITHIN THE SFA, PRESUMABLY DUE TO THE MORPHOLOGY OF CALCIUM WITHIN THE VESSEL. UPON ATTEMPTED REMOVAL OF THE RUPTURED BALLOON OVER A WIRE GUIDE AND THROUGH THE SHEATH, RESISTANCE WAS ENCOUNTERED. PER THE REPORTER, CONSIDERABLE FORCE WAS USED, AND EVENTUALLY THE BALLOON CATHETE

  Patient problems: Foreign Body In Patient

  MAUDE report 24277156 ↗
• MalfunctionJul 1, 2025Break; Break

  AS REPORTED, DURING A TRANSFEMORAL PROCEDURE TO TREAT A LOWER EXTREMITY ARTERIAL OCCLUSION VIA A CONTRALATERAL APPROACH, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH BROKE. THE TARGET LOCATION WAS THE RIGHT FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED, AND THE BIFURCATION ANGLE WAS NORMAL; HOWEVER, THE PATIENT¿S ANATOMY WAS APPROXIMATELY SEVENTY PERCENT STENOSED. ANOTHER MANUFACTURER¿S WIRE GUIDE AND SHEATH WERE USED DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH, OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE SHEATH SHAFT REPORTEDLY SEPARATED DURING DELIVERY OF THE DEVICE VIA FEMORAL ARTERY PUNCTURE. THE DILATOR AND A WIRE GUIDE WERE IN THE SHEATH LUMEN WHEN THE SEPARATION OCCURRED. A WIRE GUIDE WAS REPORTEDLY USED TO ¿SHAPE THE CURVATURE TO HOOK OUT THE BROKEN PORTION¿ OF THE SHEATH. ANOTHER DEVICE 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 PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22377181 ↗
• InjuryDec 31, 2024Break; Break

  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 21046933 ↗
• MalfunctionJul 17, 2024Difficult to Remove; Difficult to Remove

  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 19766921 ↗
• MalfunctionMar 28, 2024Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  AS REPORTED, BEFORE INSERTION OF THE DEVICE FOR A RUN OFF PROCEDURE, "EXTRA SHEATH MATERIAL" WAS NOTED AT THE END OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. ACCESS WAS OBTAINED VIA THE GROIN TO TARGET THE DISTAL PORTION OF THE OPPOSITE LEG. THE USER ATTEMPTED TO PLACE THE SHEATH OVER A COOK 0.035-INCH GUIDE WIRE; HOWEVER, RESISTANCE WAS ENCOUNTERED BEFORE INSERTION OF THE DEVICE INTO THE PATIENT. THE SHEATH WAS REMOVED AND EXTRA SHEATH MATERIAL WAS NOTED AT THE END OF THE SHEATH, WHICH NEVER ACTUALLY ENTERED THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999849 ↗
• MalfunctionJan 15, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  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 18511403 ↗
• InjuryDec 27, 2023Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING STENT PLACEMENT IN THE LEFT ILIAC ARTERY, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED. THE PATIENT, WHO WAS ALREADY HOSPITALIZED, HAD PREVIOUSLY UNDERWENT A LEFT FEMORAL-TO-POPLITEAL BYPASS PROCEDURE AND ALREADY HAD BILATERAL KISSING STENTS IN THE ILIAC ARTERIES AT THE BIFURCATION. ACCESS WAS OBTAINED IN THREE LOCATIONS, INCLUDING THE RIGHT GROIN, LEFT POPLITEAL ARTERY, AND THE LEFT TIBIAL ARTERY. THE BIFURCATION WAS STEEP, AND THE ANATOMY WAS REPORTEDLY TORTUOUS, CALCIFIED, AND SCARRED. RESISTANCE WAS ENCOUNTERED UPON ADVANCEMENT OF A 0.035-INCH, 320-CENTIMETER ANGLED HYDROPHILIC STANDARD SHAFT WIRE GUIDE. ANOTHER COOK FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS INTRODUCED UP AND OVER THE BIFURCATION FROM THE RIGHT GROIN. THE DEVICE WORKED; HOWEVER, THE SHEATH REPORTEDLY "CRINKLED", AND THEREFORE, IT WAS REPLACED WITH ANOTHER COOK FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH (COMPLAINT DEVICE). RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE SHEATH. A COOK STENT AND WIRE WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. REPORTEDLY, AFTER FULL DEPLOYMENT OF THE STENT, THE USER PULLED THE SHEATH BACK; HOWEVER, RESISTANCE WAS ENC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402776 ↗
• MalfunctionOct 27, 2023Unsealed Device Packaging; Unsealed Device Packaging

  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 18022180 ↗
• MalfunctionSep 8, 2023Difficult to Remove; Difficult to Remove

  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 17714811 ↗
• MalfunctionMar 14, 2023Peeled/Delaminated; Peeled/Delaminated

  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 16537835 ↗
• MalfunctionDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOPLASTY AND STENT PLACEMENT PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA RIGHT GROIN ACCESS, THE CLEAR EXTENSION OF THE CHECK-FLO VALVE ASSEMBLY SEPARATED FROM THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH HUB. THE SEPARATION OCCURRED WHILE THE PHYSICIAN WAS ATTEMPTING TO INJECT CONTRAST THROUGH IT. THE PHYSICIAN COMPLETED THE PROCEDURE SUCCESSFULLY BY HAVING THE NURSE TO HOLD/COVER THE HOLE WHILE INJECTING CONTRAST THROUGH THE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998662 ↗
• MalfunctionMay 24, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS DIFFICULT TO REMOVE FROM THE PATIENT. REPORTEDLY, THE SHEATH AND DILATOR WERE INSERTED OVER AN UNKNOWN WIRE AND ADVANCED OVER THE STEEP BIFURCATION. THE DILATOR WAS REMOVED, AND THE USER NOTED THAT THE SHEATH KINKED AT THE BIFURCATION. IN ADDITION TO THE BIFURCATION BEING STEEP, AN AREA OF HEAVY CALCIUM WAS NOTED AT THE RIGHT AORTIC BIFURCATION. THE PHYSICIAN ATTEMPTED TO REINSERT THE DILATOR BUT WAS UNABLE TO DO SO BECAUSE OF THE KINK. A VASCULAR SURGEON WAS CALLED TO ASSIST IN REMOVAL OF THE SHEATH, AND THE DILATOR WAS THEN ABLE TO BE ADVANCED BY TORQUEING THE DILATOR AND WIRE GUIDE. THE SHEATH WAS THEN PUSHED UP INTO THE AORTA AND WAS ABLE TO BE REMOVED. THE CASE WAS NOT COMPLETED; HOWEVER, IT IS UNKNOWN WHY. PER THE REPORTER, THERE WAS NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489250 ↗
• MalfunctionNov 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869263 ↗
• InjuryNov 2, 2021Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12737535 ↗
• InjuryDec 8, 2020Material Separation; Material Separation

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

  Patient problems: No Code Available

  MAUDE report 10969397 ↗
• MalfunctionDec 7, 2020Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING AN ATTEMPTED INTERVENTIONAL PROCEDURE INVOLVING THE LEFT SUPERFICIAL FEMORAL ARTERY, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH BECAME STUCK IN THE PATIENT. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND RESISTANCE WAS REPORTED AS THE DEVICE WAS ADVANCED OVER THE ILIAC BIFURCATION. THE ANATOMY WAS NOT TORTUOUS, SCARRED, OR CALCIFIED; ALTHOUGH, THE BIFURCATION WAS REPORTEDLY HIGH. THE USER ATTEMPTED TO ADVANCE ANOTHER MANUFACTURER'S 0.035-INCH WIRE GUIDE AND CATHETER THROUGH THE SHEATH; HOWEVER, THEY WOULD NOT ADVANCE. REPORTEDLY, IMAGING SHOWED WHAT APPEARED TO BE FLATTENING OF THE SHEATH, WHICH WAS IN PLACE LESS THAN ONE HOUR. ALTHOUGH THE SHEATH BECAME STUCK IN THE PATIENT, IT WAS REMOVED OVER ANOTHER MANUFACTURER'S WIRE GUIDE. THE PROCEDURE WAS ABORTED DUE TO THE TIME INVOLVED WITH THE SHEATH ISSUE. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO CANCELLATION OF THE PROCEDURE. THE PATIENT WILL RETURN FOR THE PLANNED INTERVENTION AT A LATER DATE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10957936 ↗
• MalfunctionNov 12, 2020Peeled/Delaminated; Material Separation; Unraveled Material; Peeled/Delaminated; Material Separation; Unraveled Material

  AS REPORTED, UPON REMOVAL OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH FROM THE RIGHT GROIN DURING AN INTERVENTIONAL PROCEDURE OF THE LEFT LOWER EXTREMITY, THE INNER LINING WAS NOTED TO HAVE SEPARATED/PEELED FROM THE DEVICE FROM APPROXIMATELY THE HALF-WAY POINT OF THE SHEATH. THE SHEATH WAS REPORTEDLY IN PLACE THROUGHOUT THE ENTIRE PROCEDURE. THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. MULTIPLE WIRE GUIDES, CROSSING CATHETERS, AND LASER ATHERECTOMY DEVICES WERE PLACED THROUGH THE SHEATH DURING THE PROCEDURE. APPROXIMATELY HALF-WAY THROUGH THE PROCEDURE, FRICTION/RESISTANCE WAS REPORTED AS THE DEVICES WERE PASSED THROUGH THE SHEATH. THE COMPLAINT DEVICE WAS REMOVED OVER AN UNSPECIFIED WIRE GUIDE AT THE COMPLETION OF THE PROCEDURE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL. THE SEPARATED PORTION OF THE INNER LINER WAS REMOVED FROM THE PATIENT WITH THE REST OF THE SHEATH. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 10828878 ↗
• MalfunctionNov 11, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  AS REPORTED, DURING A FENESTRATED ENDOVASCULAR AORTIC ANEURYSM REPAIR (FEVAR) USING A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, LEAKAGE AT THE HUB OCCURRED. WHILE INSERTING THE SHEATH INTO THE GROIN, THEY NOTICED BLOOD LEAKAGE AND THE DEAIRING TUBE WAS LOOSE FROM THE SHEATH. THE HUB WAS NOT GLUED TO THE SHEATH. THEY REPLACED THE SHEATH WITH A NEW ONE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL PATENT AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10824434 ↗
• InjuryNov 6, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 10804660 ↗
• MalfunctionNov 6, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10804620 ↗
• MalfunctionNov 6, 2020Material 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 10804529 ↗
• MalfunctionOct 15, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Information

  MAUDE report 10685698 ↗
• MalfunctionOct 15, 2020Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED 12NOV2020. ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE WAS USED DURING THE PROCEDURE; HOWEVER, THE ATHERECTOMY DEVICE WAS NOT TURNED ON WHILE IN THE SHEATH. THERE WAS VERY LITTLE RESISTANCE DURING INSERTION AND REMOVAL OF THE ATHERECTOMY DEVICE THROUGH THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683818 ↗