Flexor G56223Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002562233), received between Jan 31, 2017 and Jun 3, 2022 — classified as 4 malfunctions.

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

• MalfunctionJun 3, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A BELOW-THE-KNEE VASCULAR INTERVENTION, THE TIP OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SPLIT. THE DEVICE WAS ATTEMPTED TO BE INSERTED INTO THE PATIENT TO BE ADVANCED OVER THE ILIAC ARTERY INTO THE DISTAL SUPERFICIAL FEMORAL ARTERY. UPON INSERTION INTO THE COMMON FEMORAL ARTERY, THE DEVICE WOULD NOT ENTER THE PATIENT AT THE SKIN LEVEL DESPITE REPEATED ATTEMPTS. THE PHYSICIAN THEN OBSERVED THAT THE DISTAL END OF THE DEVICE WAS SPLIT/CRACKED. ANOTHER SHEATH WAS USED TO CONTINUE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14591723 ↗
• MalfunctionSep 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Blood Loss

  MAUDE report 10483910 ↗
• MalfunctionJul 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816521 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  INTERNATIONAL CUSTOMER REPORTED "DESSERTISSEMENT GUIDE/CATHETER" (REMOVAL GUIDE/CATHETER). SPECIFIC DETAILS RELATING TO THE PROCEDURE BEING PERFORMED, THE EVENT AND THE ACTIONS BY THE ATTENDING PHYSICIAN WERE NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. 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 6291211 ↗