Flexor G56220Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002562202), received between Oct 5, 2016 and Jan 16, 2026 — classified as 1 death, 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Difficult to Remove

  AS REPORTED, DURING AN ANGIOGRAM OF THE RIGHT LEG VIA CONTRALATERAL ACCESS FROM THE LEFT GROIN, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS DIFFICULT TO REMOVE. RESISTANCE WAS ENCOUNTERED DURING REMOVAL, AND PER THE REPORTER, THE SHEATH APPEARED TO BE STUCK WITHIN THE VESSEL AND WAS LIKELY COMPRESSED DUE TO THE PATIENT¿S SMALL AND SEVERELY CALCIFIED ARTERIES. THE SHEATH WAS SUCCESSFULLY REMOVED WITH THE DILATOR. REPORTEDLY, THE PROCEDURE WAS 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100757 ↗
• MalfunctionFeb 26, 2025Break; Break

  AS REPORTED, PRIOR TO USE DURING PREPARATION FOR AN ANGIOGRAM, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SPLIT CIRCUMFERENTIALLY. THE DEVICE WAS FLUSHED, AND THE DILATOR WAS INSERTED. WHILE WIPING THE SHEATH BEFORE USE, THE SHAFT SPLIT. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY 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 21472476 ↗
• InjuryApr 20, 2022Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED. ANOTHER MANUFACTURER'S BALLOON WAS USED THROUGH THE SHEATH. WHEN THE USER ATTEMPTED TO REMOVE THE SHEATH AND BALLOON, THE BALLOON BECAME STUCK IN THE SHEATH. THE USER THEN ATTEMPTED TO REMOVE THE SHEATH TO EXCHANGE IT, AT WHICH POINT THE SHEATH SEPARATED. THE SEPARATED PORTION OF THE SHEATH AND BALLOON WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PATIENT IS REPORTEDLY FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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: Foreign Body In Patient

  MAUDE report 14162069 ↗
• MalfunctionDec 3, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN ANGIOPLASTY OF THE RIGHT LEG VIA ACCESS IN THE LEFT GROIN, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED. THE DEVICE WAS IN PLACE FOR APPROXIMATELY THIRTY TO FORTY MINUTES. A COOK BALLOON WAS REMOVED FROM THE SHEATH WITHOUT DIFFICULTY; HOWEVER, UPON ADJUSTING THE SHEATH TO INSERT ANOTHER BALLOON, THE SHEATH REPORTEDLY SNAPPED IN HALF. THE AREA OF SEPARATION (MID SHAFT) WAS OUTSIDE THE BODY, THEREFORE, THE REMAINING PORTION OF THE SHEATH WAS MANUALLY REMOVED FROM THE PATIENT. THE ANATOMY WAS NOT SCARRED OR CALCIFIED AT THE ACCESS SITE. A COOK WIRE GUIDE WAS IN THE LUMEN OF THE DEVICE WHEN THE SEPARATION OCCURRED; HOWEVER, THE DILATOR WAS NOT IN PLACE. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE DEVICE. ANOTHER SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE OUTCOME WAS REPORTED TO BE POSITIVE. 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; No Consequences Or Impact To Patient

  MAUDE report 10941451 ↗
• MalfunctionMay 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  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 8633385 ↗
• MalfunctionAug 27, 2018Structural Problem; Deformation Due to Compressive Stress; Structural Problem; Deformation Due to Compressive Stress

  UPON OPENING THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, IT WAS REPORTED THE DISTAL END WAS KINKED (BENT) WHICH RESULTED IN SHARP EDGES. THE COMPLAINT DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. IT WAS NOT USED DURING THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817785 ↗
• InjuryApr 13, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTERIOGRAM USING A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, THE USER WAS COMING BACK THROUGH A CALCIFIED BIFURCATION AND FELT RESISTANCE WITHOUT THE DILATOR. THE DILATOR WAS PUT IN PLACE AS THE USER CONTINUED TO REMOVE THE DEVICE AND THE SHEATH FRACTURED OFF INTO THE PATIENT. A CUT DOWN PROCEDURE WAS REQUIRED TO REMOVE THE REMAINING PORTION OF THE DEVICE FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS REPORTED THAT THE PATIENT EXPERIENCED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6490387 ↗
• DeathOct 21, 2016Break; Break

  IT WAS REPORTED THE RADIOLOGY DEPARTMENT ATTEMPTED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ON THE PATIENT APPROXIMATELY TWO WEEKS PRIOR TO THIS INCIDENT, BUT COULD NOT GET THROUGH THE OCCLUSION WITH THE INTRODUCER. DURING THIS PROCEDURE FEMORAL ACCESS WAS ATTEMPTED BUT THEY WERE UNABLE TO GET THE FLEXOR THROUGH SO THEY SWITCHED TO BRACHIAL ACCESS AND WERE ABLE TO GET THE WIRE THROUGH BUT IT WAS NOT IN THE INTRODUCER. REPORTEDLY THE INTRODUCER WAS EASILY REMOVED BUT BROKE IN TWO PLACES EXPOSING THE COILING AND BECAME UN-WINDED (UNRAVELED) .THE PHYSICIAN WAS ABLE TO GET 8 MM BALLOON THROUGH AND DILATE BEFORE INSERTING THE INTRODUCER WHICH DIDN'T GO THROUGH. ABOUT 5 CM PIECE OF FLEXOR REMAINED INSIDE THE PATIENT. PATIENT HAD VERY TIGHT CALCIFICATION THAT HAD BEEN TREATED BEFORE WITH NO SUCCESS. IT IS BELIEVED THE PATIENT DIED DURING THE PROCEDURE AND IT IS ASSUMED TO HAVE BEEN DUE TO DISSECTION OF THE AORTA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE COMPLETED IF OBTAINED.

  Patient problems: Death

  MAUDE report 6046245 ↗
• MalfunctionOct 5, 2016Break; Kinked; Difficult to Remove; Break; Kinked; Difficult to Remove

  INFORMATION WAS PROVIDED THAT DURING A LOWER LEG ARTERIAL ANGIOPLASTY PROCEDURE ON THE MALE PATIENT, THE SHEATH KINKED. THE SHEATH WAS IN THE LEFT FEMORAL ARTERY AND IT WAS UP AND OVER THE BIFURCATION. AT THE END OF THE PROCEDURE, THE PHYSICIAN WAS REMOVING THE SHEATH OVER ANOTHER MANUFACTURER'S WIRE AND THE PHYSICIAN FELT A RESISTANCE AND A SLIGHT POP. THE SHEATH WAS RELEASED AND REMOVED WITHOUT ANY FURTHER COMPLICATIONS. HOWEVER, THE SHEATH WAS KINKED AND HAD A SMALL PIN HOLE AT THE KINK SITE. THE PHYSICIAN UNBENT THE SHEATH FOR EXAMINATION AND THE SHEATH BROKE IN TWO PIECES. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6000777 ↗