Flexor G49481Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002494817), received between May 10, 2017 and Jun 3, 2021 — classified as 3 malfunctions.

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

• MalfunctionJun 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE SHEATH TIP WAS DAMAGED, BUT WAS NOT SPLIT AS ORIGINALLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935162 ↗
• MalfunctionSep 18, 2018Material Frayed; Material Frayed

  DURING PREPARATION OF THE DEVICE FOR AN UNSPECIFIED PROCEDURE, IT WAS REPORTED THE PHYSICIAN NOTICED THAT THE TIP OF THE FLEXOR SHUTTLE GUIDING SHEATH WAS FRAYED, SO ANOTHER FLEXOR SHUTTLE GUIDING SHEATH WAS USED INSTEAD. THE DEVICE NEVER MADE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7884636 ↗
• MalfunctionMay 10, 2017Material Frayed; Material Frayed

  IT WAS REPORTED THAT TREATMENT OF A CAROTID ARTERY WAS CONDUCTED BY WAY OF THE RIGHT FEMORAL ARTERY USING A FLEXOR SHUTTLE GUIDING SHEATH. WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE SHEATH INTO THE PATIENT'S BODY, THE TIP OF IT GOT BURRED. ANOTHER FLEXOR SHUTTLE GUIDING SHEATH WAS USED INSTEAD WITHOUT ANY PROBLEMS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6558445 ↗