Flexor G56221Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002562219), received between Jul 15, 2016 and Mar 2, 2026 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  AS REPORTED, A FOREIGN BODY RESEMBLING A HAIR WAS NOTED IN THE PRODUCT PACKAGING OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH AT A DISTRIBUTION CENTER DURING A ROUTINE VERIFICATION PROCEDURE BEFORE THE PRODUCT WAS SENT TO THE WAREHOUSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481174 ↗
• InjuryNov 19, 2025Break; Break

  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 23598249 ↗
• MalfunctionAug 6, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, "INK OR DIRT" WAS FOUND INSIDE THE LINING OF THE PACKAGE OF THE ''FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH". THE DEVICE WAS NOT USED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE OR EXPERIENCE ANY ADVERSE EFFECT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730651 ↗
• InjuryOct 30, 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 20566724 ↗
• InjuryJun 27, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 03AUG2021. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY FOR RETROGRADE, CONTRALATERAL ACCESS FOR INTERVENTION OF THE LEFT LOWER EXTREMITY. THE SHEATH BECAME STUCK IN THE ILIAC ARTERIES PRIOR TO SEPARATION IN THE LEFT EXTERNAL ILIAC AND COMMON FEMORAL ARTERIES. THE DILATOR WAS IN PLACE UPON REMOVAL AND SEPARATION OF THE SHEATH. THE ACCESS SITE WAS NOT SCARRED. A VASCULAR CUTDOWN PROCEDURE WAS REQUIRED TO REMOVE THE SEPARATED PORTION OF THE SHEATH. PROLONGED HOSPITALIZATION WAS REQUIRED AND THE POST-OPERATIVE COURSE WAS COMPLICATED WITH SLOW WOUND HEALING AT THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072998 ↗
• InjuryJan 7, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11133732 ↗
• InjurySep 26, 2019Material Separation; Unraveled Material; Detachment of Device or Device Component; Material Separation; 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 Code Available

  MAUDE report 9124740 ↗
• MalfunctionJun 13, 2019Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695705 ↗
• MalfunctionMay 1, 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 Patient Involvement

  MAUDE report 8571801 ↗
• MalfunctionJan 14, 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 8245565 ↗
• InjuryJun 4, 2018Material Separation; Material Separation

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

  Patient problems: No Code Available

  MAUDE report 7566900 ↗
• MalfunctionMay 17, 2018Unraveled Material; Unraveled Material

  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 7523238 ↗
• InjuryFeb 20, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TIBIAL ARTERY INTERVENTION, THE DISTAL TIP OF THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED UPON REMOVAL, EXPOSING THE METAL COILING. SURGICAL INTERVENTION (CUT DOWN PROCEDURE) WAS REQUIRED TO REMOVE THE DEVICE PORTION FROM THE PATIENT'S ANATOMY. THE SHEATH WAS PLACED IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) VIA CONTRALATERAL APPROACH. THE FOLLOWING DEVICES WERE INSERTED THROUGH THE LUMEN OF THE SHEATH PRIOR TO REMOVAL: GLIDEWIRE (OTHER MANUFACTURER), TIBIAL BALLOONS AND CATHETERS (MANUFACTURER UNKNOWN). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7282767 ↗
• MalfunctionMay 31, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION PROCEDURE USING A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH AT THE FEMORAL ARTERY, THE VALVE STARTED TO LEAK AT THE END OF THE CASE. ACCESS WAS GAINED CONTRALATERALLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6602375 ↗
• MalfunctionMay 15, 2017Material Separation

  THE LINING INSIDE SHEATH PEELED AWAY FROM INNER SHEATH WHILE PULLING OUT GLIDE WIRE. SHEATH WAS REMOVED AND REPLACED WITH A NEW ONE. 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 6566353 ↗
• InjuryApr 21, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT AT THE END OF A SUBCLAVIAN ARTERIOGRAM AND STENTING PROCEDURE THE SHEATH WAS BEING REMOVED, WITHOUT A DILATOR IN PLACE, FROM THE RIGHT RADIAL ARTERY. THE ARTERY HAD A SPASM AROUND THE SHEATH. THE PHYSICIAN PULLED ON THE SHEATH TO REMOVE IT AND THE SHEATH BROKE. PRESSURE WAS HELD AT SITE WHILE THE PHYSICIAN TRIED TO REMOVE THE REMAINING PIECE OF SHEATH WITH A CLAMP. THE PHYSICIAN WAS UNABLE TO REMOVE THE REMAINING PIECE OF SHEATH FROM THE PATIENT. APPROXIMATELY 40-45 CM REMAINED IN THE PATIENT'S ARTERY. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL TO HAVE A SURGICAL CUT DOWN PROCEDURE PERFORMED TO SURGICALLY REMOVE THE REMAINING SHEATH AND REPAIR THE TEAR IN THE ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6511037 ↗
• MalfunctionFeb 6, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, AT THE END OF A PROCEDURE UPON REMOVAL, THE SHEATH BECAME STUCK AND WOULD NOT COME OUT. AN ATTEMPT WAS MADE TO REINSERT THE DILATOR TO REMOVE THE SHEATH, WHICH DID NOT WORK. THE STAFF MADE ANOTHER ATTEMPT AT REMOVAL BY PLACING A BALLOON IN THE SHEATH, THIS ALSO DID NOT WORK. EVENTUALLY THE SHEATH WAS REMOVED BUT WAS REPORTEDLY IN BAD SHAPE. THE PATIENT WAS UNHARMED AND NO ADDITIONAL PROCEDURES WERE REQUIRED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304991 ↗
• InjuryOct 20, 2016Material Separation; Material Separation

  A PERIPHERAL REVASCULARIZATION OF RIGHT SUPERFICIAL FEMORAL ARTERY PROCEDURE WAS BEING CONDUCTED ON A PATIENT, WHO HAD A HEAVILY TORTUOUS AND CALCIFIED ANATOMY. THE PHYSICIAN AND TECH REPORTED SIGNIFICANT DIFFICULTY ADVANCING THE SHEATH, CONTRALATERAL FROM THE LEFT ACCESS COMMON FEMORAL POINT. AFTER APPROXIMATELY 30 MINUTES OF EXPERIENCED DIFFICULTY, THEY SUCCESSFULLY ADVANCED THE SHEATH. (THE SHEATH WAS INITIALLY ADVANCED OVER THE WIRE THROUGH AN EXISTING LEFT ILIAC ARTERY STENT). HOWEVER, THE PROCEDURE WAS ULTIMATELY NOT SUCCESSFUL BECAUSE THEY "FAILED TO CROSS THE PERIPHERAL LESION". IT WAS REPORTED THAT THE FAILURE WAS NOT RELATED TO THE PRODUCT. AT THIS TIME, A DECISION WAS MADE TO ABANDON THE PROCEDURE AND BRING THE PATIENT BACK FOR ANOTHER PROCEDURE AT ANOTHER TIME. DUE TO THE PATIENTS' ACTIVATED CLOTTING TIME (ACT) LEVELS, THE SHEATH WAS LEFT IN THE LEFT GROIN AND THE PATIENT WAS TRANSPORTED TO DAY SURGERY. ONCE THE ACT LEVELS IMPROVED, THE TECH ATTEMPTED TO REMOVE THE SHEATH, BUT ENCOUNTERED SIGNIFICANT RESISTANCE. THE PHYSICIAN WAS CALLED FOR ASSISTANCE AND AS THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH, SIGNIFICANT FORCE WAS USED. THIS RESULTED IN THE SHEATH SEPARATING,

  Patient problems: No Code Available

  MAUDE report 6043529 ↗
• MalfunctionJul 15, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN IT WAS TIME TO REMOVE THE SHEATH, IT WAS NOTED THAT THE DIAPHRAGM FAILED / WAS LEAKING. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5797690 ↗