Flexor G11617Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002116177), received between Dec 5, 2016 and Oct 15, 2025 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A THREE-FENESTRATION FENESTRATED ENDOVASCULAR ANEURYSM REPAIR PROCEDURE, THE HUB SEPARATED FROM A FLEXOR INTRODUCER SHEATH UPON REMOVAL OF THE DEVICE FROM A FENESTRATION. THE SHEATH WAS ADVANCED INTO ANOTHER MANUFACTURER'S 16FR DEVICE, WITH NO PROBLEMS DURING ACCESS. THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. A COOK CATHETER AND OTHER MANUFACTURER'S WIRE GUIDE WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT FELT UPON INSERTION/REMOVAL OF THE SHEATH NOR WAS RESISTANCE FELT DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. UPON REMOVAL OF THE SHEATH BY THE HUB FROM THE OTHER MANUFACTURER'S 16FR DEVICE AND OVER ANOTHER MANUFACTURER'S WIRE GUIDE, THE HUB SEPARATED. THE DILATOR WAS NOT INSERTED PRIOR TO REMOVAL. THE SHEATH WAS COMPLETELY REMOVED MANUALLY AS IT WAS "CATCHABLE" OUTSIDE OF THE 16FR DEVICE. A NEW SHEATH FROM THE SAME LOT WAS INSERTED AND USED WITHOUT PROBLEMS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 23291968 ↗
• MalfunctionDec 5, 2016Material Separation; Material Separation

  IT WAS REPORTED DURING A FENESTRATED THORACO PROCEDURE AS THE INTRODUCER SHEATH WAS BEING BROUGHT ONTO ANOTHER MANUFACTURER'S WIRE THE SHEATH DETACHED FROM THE TAP SECTION. THE WIRE WAS REPORTED TO BE COMING FROM THE BRACHIAL (ABOVE) CROSSING THE GREAT VESSELS TO THE DESCENDING AORTA AT THE TIME. ANOTHER DEVICE WAS USED TO SUCCESSFULLY 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 6145481 ↗