Flexor G29997Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002299979), received between May 12, 2017 and Aug 4, 2020 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2020Material Frayed; Material Frayed

  AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE A FLEXOR ANSEL GUIDING SHEATH WAS REMOVED FROM ITS PACKAGING AND THE TIP OF THE OUTER SHEATH WAS FOUND TO BE FRAYED OR JAGGED. THE DEVICE PACKAGING WAS STORED ON THE HANGING RACK AND HAD NO DAMAGE. ANOTHER DEVICE WITH THE SAME SPECIFICATIONS WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT, SO NO PORTION OF THE DEVICE REMAINED WITHIN THE PATIENT. THIS INCIDENT DID NOT RESULT IN THE PATIENT NEEDING ADDITIONAL PROCEDURES. NO ADVERSE EFFECTS TO THE PATIENT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363495 ↗
• MalfunctionAug 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  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 8888639 ↗
• InjuryFeb 19, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN INTERVENTION, THE FLEXOR ANSEL GUIDING SHEATH BROKE INSIDE OF THE PATIENT'S ANATOMY. THE BROKEN PORTION OF THE SHEATH HAD TO BE RETRIEVED FROM THE PATIENT'S ARTERY, WHICH CONSIDERABLY LENGTHENED THE AMOUNT OF TIME TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7280472 ↗
• MalfunctionMay 12, 2017Material Frayed; Kinked

  IT WAS REPORTED THE SHEATH BECAME FRAYED UPON ATTEMPTING TO INSERT THE DEVICE INTO THE PATIENT'S BODY. THE DEVICE WAS SUBSEQUENTLY CHECKED OUTSIDE OF THE PATIENT'S BODY AND IT WAS CONFIRMED TO BE KINKED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6563955 ↗