Flexor G56236Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00827002562363), received between Nov 15, 2016 and Feb 19, 2026 — classified as 12 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH'S SHAFT UNRAVELED. ACCESS WAS OBTAINED VIA THE COMMON FEMORAL ARTERY TO TARGET THE CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA). ANOTHER MANUFACTURER'S CATHETER WAS USED DURING THE PROCEDURE. UPON REMOVAL FROM THE PATIENT, RESISTANCE WAS ENCOUNTERED AND THE COMPLAINT DEVICE "CAUGHT ON SOME CALCIUM" AND UNRAVELED. THE DILATOR WAS NOT IN PLACE WHEN THE DEVICE UNRAVELED. THE USER DID NOT HAVE TROUBLE REMOVING THE DEVICE FROM THE PATIENT MANUALLY. THE PROCEDURE HAD SUCCESSFULLY BEEN COMPLETED WITH THE COMPLAINT DEVICE. 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 OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393153 ↗
• MalfunctionNov 11, 2024Break; Break

  AS REPORTED, UPON OPENING THE DEVICE PACKAGE, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH'S STOPCOCK WAS FOUND TO BE BROKEN. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THAT ONE ARM OF THE STOPCOCK HAD BROKEN OFF. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. 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 20653404 ↗
• MalfunctionJul 27, 2023Break; Break

  AS REPORTED, DURING AN ANGIOGRAPHY PROCEDURE, THE TIP OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. ANOTHER MANUFACTURER'S WIRE GUIDE WAS PLACED, FOLLOWED BY AN UNSPECIFIED PIGTAIL ANGIOGRAPHY CATHETER, WHICH WAS PLACED TO CROSS THE ILIAC ARTERY. ONCE THE ANGIOGRAPHY CATHETER WAS ADVANCED OVER THE ILIAC ARTERY, THE COMPLAINT DEVICE WAS PLACED TO ESTABLISH A MORE EFFECTIVE "SUPPORT ACCESS". SIGNIFICANT RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE SHEATH. DURING THE ANGIOGRAM, THE TIP OF THE SHEATH WAS NOT SEEN. THE SHEATH WAS IMMEDIATELY REMOVED FROM THE PATIENT, WITHOUT ENCOUNTERING SIGNIFICANT RESISTANCE. ANGIOGRAPHY WAS PERFORMED ON THE AFFECTED LIMB, STARTING FROM THE KNEE TO THE TIBIOFIBULAR TRUNK, POPLITEAL ARTERY, FEMORAL ARTERY, AND ILIAC ARTERY TO THE PUNCTURE POINT. NO FOREIGN BODY WAS OBSERVED. THE USER ASSUMED THAT THE TIP SEPARATED PRIOR TO INSERTION INTO THE PATIENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 INITIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405918 ↗
• MalfunctionApr 10, 2023Peeled/Delaminated; Peeled/Delaminated

  AS ORIGINALLY REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM WITH PLACEMENT OF A BALLOON-DILATED STENT WITHIN THE COMMON FEMORAL ARTERY, ANOTHER MANUFACTURER'S WIRE GUIDE COULD NOT BE INSERTED INTO THE HUB OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. THE DILATOR WAS INSIDE THE SHEATH AT THE TIME OF THE EVENT. ANOTHER SHEATH WAS USED 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, DELAMINATION WAS NOTED WITHIN THE FLARE OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709627 ↗
• InjuryMar 22, 2023Break; Unraveled Material; Break; Unraveled Material

  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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592061 ↗
• MalfunctionAug 23, 2022Peeled/Delaminated; Peeled/Delaminated

  AS ORIGINALLY REPORTED, PRIOR TO USE, THE DILATOR WOULD NOT INSERT INTO A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. UPON RETURN AND EVALUATION OF THE DEVICE, DELAMINATION AND COIL EXPOSURE WERE NOTED WITHIN THE FLARE OF THE SHEATH. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278587 ↗
• InjuryMay 9, 2022Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE INVOLVING THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH BECAME STUCK IN THE PATIENT DURING INSERTION OF THE DEVICE. ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY TO TARGET A LESION WITHIN THE SFA. RESISTANCE WAS NOT REPORTED, AND THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. THE SHEATH KINKED UPON ADVANCEMENT OVER THE BIFURCATION. THE USER ATTEMPTED TO CROSS THE SHEATH SEVERAL TIMES, USING MULTIPLE WIRES AND CATHETERS, WHICH CAUSED THE SHEATH TO BECOME STUCK IN THE ILIAC ARTERY. THE LEFT SUPERFICIAL FEMORAL ARTERY WAS THEN ACCESSED PERCUTANEOUSLY AND A WIRE AND CATHETER WERE PASSED THROUGH THE SHEATH IN A RETROGRADE FASHION. THE SHEATH WAS THEN ABLE TO BE REMOVED, AND A NEW SHEATH WAS USED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336676 ↗
• MalfunctionApr 20, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  AS REPORTED, DURING AN INTERVENTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS DIFFICULT TO REMOVE FROM THE PATIENT. ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY TO TARGET THE CONTRALATERAL SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE SHEATH FLATTENED DURING ADVANCEMENT OF THE DEVICE THROUGH TORTUOUS ILIACS AND OVER THE BIFURCATION. ANCILLARY DEVICES, INCLUDING OTHER MANUFACTURERS' CATHETERS AND WIRES, WERE THEN DIFFICULT TO ADVANCE THROUGH THE SHEATH. THE SHEATH, WHICH WAS IN PLACE FOR APPROXIMATELY 45 MINUTES, WAS THEN REPORTEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THE DILATOR WAS INSERTED AS FAR AS POSSIBLE, AND THE SHEATH WAS REMOVED OVER A WIRE GUIDE. THERE WAS NO INJURY 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14163403 ↗
• MalfunctionFeb 22, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, PRIOR TO A PROCEDURE IN THE LEG, FOREIGN MATTER WAS FLUSHED OUT OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. THIS OCCURRED WHILE PREPPING THE DEVICE. THE FOREIGN MATTER APPEARED TO POSSIBLY BE DUST OR SOMETHING SIMILAR. THE DEVICE WAS DISPOSED OF AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579228 ↗
• InjuryFeb 16, 2022Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY WITH STENT PLACEMENT VIA A CROSS-OVER APPROACH, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED. THE SHEATH SEPARATED DURING PLACEMENT OF THE DEVICE INTO TORTUOUS AND CALCIFIED VESSELS. PART OF THE SEPARATED SHEATH MIGRATED TO THE ILIAC ARTERY. AN OPEN SURGICAL PROCEDURE WAS PERFORMED VIA THE FEMORAL ARTERY AND THE SEPARATED PORTION OF THE DEVICE WAS RETRIEVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13544207 ↗
• MalfunctionNov 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE THE DISTAL TIP OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SPLIT WHILE IT WAS BEING INSERTED. ANOTHER NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THIS DID NOT RESULT IN 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

  MAUDE report 12870882 ↗
• InjuryNov 10, 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

  MAUDE report 12788193 ↗
• MalfunctionJun 17, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 25AUG2021. THE PATIENT'S ANATOMY WAS CALCIFIED, BUT TORTUOSITY OR SCARRING WAS NOT REPORTED. THE ACCESS SITE WAS THE LEFT COMMON FEMORAL WITH RETROGRADE ACCESS, AND THE SHEATH WAS ADVANCED TO THE RIGHT COMMON FEMORAL ARTERY OVER THE AORTIC BIFURCATION FOR INTERVENTION OF THE RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES. AFTER THE SHEATH WAS IN PLACE FOR "LESS THAN AN HOUR," WHEN BEING WITHDRAWN, THE SEPARATION OCCURRED. ANOTHER MANUFACTURER'S WIRE WAS IN PLACE DURING THE SEPARATION. "MILD" RESISTANCE ON INSERTION OF THE DEVICE AND "SIGNIFICANT" RESISTANCE DURING THE WITHDRAWAL WAS REPORTED. THE DEVICE WAS NOT FULLY DETACHED, AND THE DEVICE WAS REMOVED WITH A CLAMP OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016877 ↗
• MalfunctionFeb 16, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 11331779 ↗
• MalfunctionJun 8, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

  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 10129489 ↗
• MalfunctionMay 4, 2020Material Separation; Material Separation

  AS REPORTED, PRIOR TO PATIENT CONTACT, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH KINKED AS IT WAS ADVANCED OVER ANOTHER MANUFACTURER'S 0.035-INCH WIRE GUIDE. UPON RETURN AND INITIAL INSPECTION OF THE DEVICE ON (B)(6) 2020, THE SHEATH MATERIAL WAS FOUND TO BE SEPARATED EIGHT CENTIMETERS FROM THE DISTAL TIP. 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.

  Patient problems: No Patient Involvement

  MAUDE report 10021702 ↗
• MalfunctionNov 14, 2019Material Split, Cut or Torn; 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 Consequences Or Impact To Patient

  MAUDE report 9323931 ↗
• MalfunctionNov 4, 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 9272546 ↗
• MalfunctionSep 6, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 8969728 ↗
• MalfunctionJul 17, 2019Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED, AT THE END OF AN ARTERIOGRAM INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH UNCOILED AND THE SHAFT SEPARATED INTO TWO SECTIONS. THIS OCCURRED AS THE DEVICE WAS BEING PULLED BACK OVER THE BIFURCATION UPON REMOVAL OF THE DEVICE FROM THE GROIN. THE TWO SECTIONS WERE ATTACHED BY THE COIL AND WERE ABLE TO BE REMOVED WITH THE REST OF THE DEVICE OVER AN UNKNOWN WIRE. THE DILATOR WAS NOT INSERTED UPON REMOVAL OR AT THE TIME OF SEPARATION. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITH THE COMPLAINT DEVICE PRIOR TO THE EVENT AND THE PATIENT WAS REPORTEDLY "FINE". 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798324 ↗
• MalfunctionMay 15, 2019Material Separation; Material Separation

  IT WAS REPORTED, A MALE PATIENT WAS UNDERGOING AN UNSPECIFIED PROCEDURE IN WHICH A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS USED. IT WAS DIFFICULT TO PULL THE SHEATH OVER THE AMPLATZ WIRE GUIDE WHERE THEY HAD PRE DILATED WITH FIVE, SIX, AND SEVEN FRENCH BEFOREHAND. WHEN THE DOCTOR REMOVED THE COMPLAINT SHEATH, IT BROKE. ALL PARTS WERE RETRIEVED AND NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612910 ↗
• MalfunctionMar 8, 2019Unraveled Material; Detachment of Device or Device Component; Unraveled Material; 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 Consequences Or Impact To Patient

  MAUDE report 8405227 ↗
• InjuryMar 1, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION REGARDING THIS EVENT WAS PROVIDED ON 08MAY2019. THIS PATIENT WAS HAVING PAIN AFTER THIS PROCEDURE AND CAME IN FOR A PROCEDURE ON (B)(6) 2019. A PIECE OF A MEDICAL DEVICE WAS FOUND IN THE PATIENT AND RETRIEVED. THE CUSTOMER BELIEVES THAT THE PIECE IS PART OF THE COMPLAINT DEVICE FROM THIS EVENT.

  Patient problems: No Code Available; Pain

  MAUDE report 8383114 ↗
• MalfunctionFeb 14, 2019Crack; Crack

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8339035 ↗
• MalfunctionJan 22, 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 Known Impact Or Consequence To Patient

  MAUDE report 8267121 ↗