Flexor G56222Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002562226), received between Jan 31, 2017 and Jan 14, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  AS REPORTED BY A DISTRIBUTOR, PRIOR TO USE FOR AN ENDOVASCULAR AORTIC REPAIR PROCEDURE, CONDENSATION WAS NOTED IN A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH'S PACKAGE. PER THE DISTRIBUTOR, IT APPEARS AS THOUGH SOMETHING HEAVY WAS ON THE DEVICE OR ROLLED OVER THE DEVICE, AS "MARKS ON THE BOX" ALIGNED WITH THE SHEATH DAMAGE. THE DISTRIBUTOR CONDUCTED AN INTERNAL INVESTIGATION AND CONCLUDED THAT THE DAMAGE WAS NOT ATTRIBUTED TO THE DISTRIBUTOR'S PROCESSES. PER THE DISTRIBUTOR, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH IS GENERALLY USED WITH "V12 STENTS" IN "HIGH STRESS/RISK/COST PROCEDURES"; HOWEVER, THE COMPLAINT DEVICE WAS NOT USABLE AND THEREFORE, THE STENTS WERE NOT PLACED AS INTENDED. THE PATIENT WILL BE MONITORED AND MAY RETURN FOR STENT PLACEMENT IN THE FUTURE. 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 24071000 ↗
• MalfunctionMay 3, 2024Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, UPON COMPLETION OF AN ANGIOGRAM OF THE LEFT LEG, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH BROKE UPON REMOVAL OF THE DEVICE FROM THE PATIENT. ACCESS WAS OBTAINED IN THE RIGHT GROIN TO TARGET THE LEFT COMMON FEMORAL ARTERY. THE ANATOMY WAS CALCIFIED, AND THE PATIENT HAD A HISTORY OF PERIPHERAL ARTERY DISEASE, TYPE II DIABETES, AND HYPERTENSION. THE AORTIC BIFURCATION ANGLE WAS STEEP, WITH VISIBLE CALCIUM DEPOSITS NOTED. AN UNKNOWN TRIPLE LUMEN CATHETER WAS ALSO USED DURING THE PROCEDURE. UPON COMPLETION OF THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PULL THE SHEATH BACK TO THE RIGHT FEMORAL ARTERY; HOWEVER, RESISTANCE WAS NOTED NEAR THE AORTIC BIFURCATION, AND THE DISTAL END OF THE SHEATH SEPARATED. THE DILATOR WAS NOT REINSERTED PRIOR TO ATTEMPTED REMOVAL OF THE SHEATH, AND NOTHING WAS IN THE SHEATH LUMEN AT THE TIME OF SEPARATION. THE SHEATH WAS APPROXIMATELY TWO-THIRDS OUT OF THE BODY WHEN THE SEPARATION OCCURRED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SHEATH BUT WAS UNABLE TO DO SO. A ¿TABLE¿ WIRE WAS INSERTED INTO THE SHEATH FOR ADDITIONAL SUPPORT. ANOTHER MANUFACTURER'S 6-FRENCH CATHETER WAS THEN INSERTED OVER THE ¿TABLE¿ WIRE, WHICH WAS UNABLE TO ADVANCE IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239828 ↗
• MalfunctionDec 3, 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 9401900 ↗
• MalfunctionOct 19, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING INSPECTION OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, IT WAS REPORTED THAT THERE WAS A "PIECE OF AN UNIDENTIFIED PARTICLE INSIDE THE PRIMARY PACKAGE". THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6963243 ↗
• MalfunctionMay 16, 2017Material Deformation

  WHEN THE PHYSICIAN ADVANCED THE INTRODUCER OVER THE WIRE GUIDE, HE NOTICED THE DISTAL END OF THE INTRODUCER WAS DEFORMED. AT THIS POINT THE PHYSICIAN REMOVED THE INTRODUCER AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE AND 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 Known Impact Or Consequence To Patient

  MAUDE report 6570981 ↗
• MalfunctionJan 31, 2017Unraveled Material; Unraveled Material

  CUSTOMER REPORTED THAT THE DEVICE WAS PLACED INTO THE COMMON FEMORAL FOR AN UNSPECIFIED PROCEDURE. A DILATOR WAS PLACED WITHIN THE LUMEN OF THE SHEATH PRIOR TO REMOVAL FROM THE PATIENT. THE DEVICE REPORTEDLY BEGAN TO UNRAVEL UPON REMOVAL OF THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED WITH A NEW DEVICE 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 Known Impact Or Consequence To Patient

  MAUDE report 6291718 ↗