Flexor G36393Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002363939), received between Dec 20, 2017 and May 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Unraveled Material; Unraveled Material

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE INNER COIL OF A FLEXOR RAABE GUIDING SHEATH UNRAVELED AND PROTRUDED FROM THE HUB. THE SHEATH WAS FLUSHED, AND THE USER ATTEMPTED TO REMOVE THE DILATOR; HOWEVER, AS THE DILATOR WAS WITHDRAWN FROM THE SHEATH, THE INNER COIL CAME OUT OF THE SHEATH WITH THE DILATOR. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SHEATH. 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 22060042 ↗
• MalfunctionDec 31, 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 Consequences Or Impact To Patient

  MAUDE report 9535442 ↗
• MalfunctionJun 19, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED, DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE VIA THE PATIENT'S LEG, THE FLEXOR RAABE GUIDING SHEATH BECAME "ELONGATED". AFTER ATTEMPTING TO INSERT THE COMPLAINT DEVICE INTO A 12FR SHEATH, IT BECAME "STUCK". THE COMPLAINT DEVICE WAS REMOVED WITH "QUITE A BIT OF FORCE". THE PHYSICIAN FOUND THE COMPLAINT DEVICE WAS "PROLONGED". THE COMPLAINT DEVICE DID NOT SEPARATE. REPORTEDLY, THE PATIENT'S VASCULATURE WAS NEITHER CALCIFIED NOR TORTUOUS. THERE WAS NO ANGULATION. 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. ADDITIONAL INFORMATION REGARDING THIS EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7615988 ↗
• MalfunctionDec 20, 2017Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT FOLLOWING RETRIEVAL OF AN INFERIOR VENA CAVA (IVC) FILTER, THE FLEXOR RAABE GUIDING SHEATH UNRAVELED AT THE TIP WHILE IT WAS BEING REMOVED. THE UNRAVELED PORTION OF THE SHEATH DID NOT DETACH FROM THE DEVICE, AND THE ENTIRE SHEATH WAS ABLE TO BE REMOVED. THE ACCESS SITE UTILIZED DURING THE PROCEDURE WAS THE INTERNAL JUGULAR (IJ) VEIN; ANOTHER MANUFACTURER'S GOOSENECK SNARE WAS USED DURING THE IVC FILTER RETRIEVAL. 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 7135529 ↗