Flexor G32373Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002323735), received between Mar 17, 2017 and Aug 23, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 26, 2025Open, Classified

   Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

   Z-0993-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 16SEP2019. AS REPORTED, ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR VEIN, NOT IN THE GROIN. AS THE DILATOR MADE CONTACT WITH THE PATIENT'S SKIN, THE DEVICE'S SIDEARM DETACHED AND FELL TO THE FLOOR. THE DEFECT WAS NOTICED IMMEDIATELY BY THE PERFORMING PHYSICIAN, WHO REPLACED THE DEVICE WITH ANOTHER, UNKNOWN SHEATH TO COMPLETE THE PROCEDURE. NO FURTHER 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 8925057 ↗
• MalfunctionMar 1, 2018Split; Split

  IT WAS REPORTED THAT DURING IMPLANTATION OF ANOTHER MANUFACTURER'S ILIAC STENT GRAFT, THE SURGEON TRIED TO GAIN ACCESS BACK INTO THE RECENTLY DEPLOYED STENT AS IT HAD MOVED. PRIOR TO RE-INSERTION OF THE FLEXOR GUIDING SHEATH, IT WAS OBSERVED THAT THE DILATOR HAD SPLIT; THEREFORE, THE SHEATH WAS NOT USED. THE SHEATH WAS REPORTED TO HAVE BEEN PREVIOUSLY UTILIZED. AN ANGIOGRAM, ILIAC STENTING, AND AN ANGIOPLASTY WERE PERFORMED; THE CASE WAS ABLE TO BE SUCCESSFULLY COMPLETED. ANOTHER MANUFACTURER'S SHEATH FOLLOWED BY THE FLEXOR GUIDING SHEATH WITH CHECK-FLO VALVE, WIRE GUIDE (MANUFACTURER UNSPECIFIED), AND THE ILIAC STENT GRAFT WERE UTILIZED. ACCESS TO THE ANEURYSM WAS GAINED VIA BILATERAL (RIGHT AND LEFT) GROIN PUNCHER. 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 7306889 ↗
• MalfunctionMar 17, 2017Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT DURING AN IVC FILTER RETRIEVAL THE FLEXOR GUIDING SHEATH UNRAVELLED WHEN BEING USED. THE PATIENT WAS UNHARMED. NO ADDITIONAL DETAILS WERE RECEIVED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6412918 ↗