Flexor G12606Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002126060), received between Aug 31, 2016 and Aug 8, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2017Material Separation; Wrinkled; Material Separation; Wrinkled

  A FLEXOR RAABE GUIDING SHEATH WAS USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT WHEN INSERTING THE FLEXOR RAABE GUIDING SHEATH IT BEGAN TO PEEL BACK ON ITSELF. IT WAS ALSO REPORTED THAT THE END USER STOPPED, REMOVED THE SHEATH AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS TO THE PATIENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY AND NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774100 ↗
• InjuryMar 10, 2017Leak/Splash; Leak/Splash

  DURING A PROCEDURE TO EXCLUDE A THORACIC ABDOMINAL ANEURYSM ON THE (B)(6) FEMALE PATIENT, THE INTRODUCER VALVE BEGAN TO LEAK. AS THE ROOM WAS DARK DURING THE PROCEDURE, THE LEAKAGE WAS NOT NOTED UNTIL THE PATIENT'S BLOOD LOSS BEGAN TO DRIP ONTO THE FLOOR. AS THE PATIENT BLOOD LOSS EQUALED APPROX. 1 LITER, A TRANSFUSION WAS GIVEN AT THIS POINT. THE INTRODUCER HAS BEEN EXCHANGED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: Blood Loss

  MAUDE report 6394948 ↗
• MalfunctionAug 31, 2016Material Separation; Material Separation

  IT WAS REPORTED A SUBCLAVIAN PROCEDURE WAS BEING PERFORMED ON A STABBING VICTIM WHEN THE CHECK-FLO VALVE CAME APART. AS OF THE FILING OF THIS REPORT NO OTHER INFORMATION IS AVAILABLE. 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 5917575 ↗