Flexor G29999Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002299993), received between May 12, 2017 and Aug 16, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557636 ↗
• MalfunctionJan 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264117 ↗
• MalfunctionDec 1, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, THE DISTAL PORTION OF A FLEXOR ANSEL GUIDING SHEATH TORE WHEN IT WAS INSERTED. THE ACCESS SITE WAS THE FEMORAL ARTERY. PAD WAS ALSO NOTED. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908800 ↗
• MalfunctionDec 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, IN THE MIDDLE OF A FENESTRATED ENDOGRAFT PLACEMENT PROCEDURE, THE HUB SEPARATED FROM A FLEXOR ANSEL GUIDING SHEATH AS THE DEVICE WAS PULLED BACK FOR REPOSITIONING. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY AND THE SHEATH WAS ADVANCED TO THE RIGHT RENAL ARTERY. THE SHEATH WAS IN PLACE FOR 23.5 MINUTES. THE ANATOMY WAS NOT TORTUOUS, CALCIFIED OR SCARRED. RESISTANCE WAS NOT REPORTED. THE HUB WAS USED TO PULL THE SHEATH DURING REPOSITIONING. THE DILATOR WAS NOT IN PLACE AT THE TIME OF HUB SEPARATION; HOWEVER, AN UNKNOWN WIRE GUIDE AND CATHETER WERE IN THE LUMEN OF THE DEVICE. APPROXIMATELY TEN MILLILITERS OF BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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 Consequences Or Impact To Patient

  MAUDE report 10991676 ↗
• MalfunctionJan 2, 2020Material Frayed; Material Frayed

  AS REPORTED, DURING AN ENDOVASCULAR TREATMENT PROCEDURE, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH FRAYED. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. AS THE USER ATTEMPTED TO INSERT THE SHEATH, THE TIP OF THE DEVICE BECAME CAUGHT IN THE PUNCTURE SITE AND FRAYED. NO CALCIFICATION WAS NOTED AT THE PUNCTURE SIRE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539563 ↗
• MalfunctionAug 10, 2019Material Frayed; Material Frayed

  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 8881661 ↗
• MalfunctionJul 10, 2019Material Frayed; Material Frayed

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777040 ↗
• MalfunctionMay 16, 2019Material Frayed; Material Frayed

  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 8616298 ↗
• MalfunctionFeb 8, 2019Material Frayed; Material Frayed

  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 8322143 ↗
• MalfunctionDec 13, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  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 8160630 ↗
• MalfunctionOct 4, 2018Material Frayed; Material Frayed

  IT WAS REPORTED, WHILE FLUSHING THE FLEXOR ANSEL GUIDING SHEATH PRIOR TO USE, THE TIP WAS NOTED TO BE FRAYED. THE DEVICE NEVER MADE PATIENT CONTACT. ANOTHER FLEXOR ANSEL GUIDING SHEATH WAS ABLE TO BE USED. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED. ACCORDING TO THE COMPLAINANT, THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 7935687 ↗
• MalfunctionJul 11, 2018Material Frayed; Difficult to Advance; Material Frayed; Difficult to Advance

  IT WAS REPORTED, DURING AN ENDOVASCULAR THERAPY PROCEDURE, THE FLEXOR ANSEL GUIDING SHEATH HAD DIFFICULTY ADVANCING IN THE PATIENT'S ANATOMY AND WAS REMOVED. A FRAY WAS NOTED ON THE TIP OF THE DEVICE. DURING THE PROCEDURE, CONTRALATERAL APPROACH WAS GAINED FROM THE LEFT COMMON FEMORAL ARTERY (CFA) IN ORDER TO PRE-DILATE THE VESSEL WITH A 6FRENCH SHORT SHEATH. THE COMPLAINT DEVICE WAS INSERTED, AFTER THE PRE-DILATION, FOR STENT GRAFT PLACEMENT WITH ANOTHER MANUFACTURER'S STENT. IT WAS AT THIS TIME THERE WAS DIFFICULTY ADVANCING THE FLEXOR ANSEL GUIDING SHEATH. REPORTEDLY, ANOTHER FLEXOR ANSEL GUIDING SHEATH WAS INSERTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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 7678370 ↗
• MalfunctionJun 5, 2017Material Deformation; Material Deformation

  AN INTERNATIONAL CUSTOMER REPORTED THAT UPON OPENING THE PACKAGE, THE DILATOR WAS KINKED. ANOTHER ONE FROM A DIFFERENT LOT WAS USED FOR THE PROCEDURE. FURTHER INVESTIGATION REVEALED THAT THE DISTAL TIP OF THE FIRST DILATOR WAS NICKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6612763 ↗
• MalfunctionMay 18, 2017Failure to Advance

  WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE COMPLAINT DEVICE OVER THE WIRE GUIDE, IT WOULD NOT ADVANCE INTO THE PATIENT DUE TO A GAP BETWEEN INTRODUCER AND SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO ADVERSE EVENTS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575325 ↗
• MalfunctionMay 18, 2017Failure to Advance

  WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE COMPLAINT DEVICE OVER THE WIRE GUIDE, IT WOULD NOT ADVANCE INTO THE PATIENT DUE TO A GAP BETWEEN INTRODUCER AND SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO ADVERSE EVENTS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575230 ↗
• MalfunctionMay 17, 2017Material Frayed; Failure to Advance

  THE INFORMATION RECEIVED INDICATED THAT THE SHEATH WOULD NOT ADVANCE DUE TO FRAYING OF THE TIP. THE DEVICE WAS ADVANCED CONTRALATERALLY TO THE LESION OF SUPERFICIAL FEMORAL ARTERY (SFA); HOWEVER IT WOULD NOT ADVANCE, DUE TO THE FRAY OF THE TIP OF THE SHEATH. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6573285 ↗
• MalfunctionMay 17, 2017Material Frayed

  WHILE PREPARING TO TREAT CHRONIC TOTAL OCCLUSION IN THE SUPERIOR FEMORAL ARTERY, THE PHYSICIAN DISCOVERED THAT THE DILATOR TIP WAS FRAYED. THIS OCCURRED PRIOR TO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE HAVE BEEN NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION REPORTED.

  Patient problems: Occlusion

  MAUDE report 6571789 ↗
• MalfunctionMay 12, 2017Difficult to Insert

  THE DEVICE WAS APPROACHED FROM THE RIGHT FEMORAL ARTERY CONTRALATERALLY DURING PROCEDURE OF COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY. HOWEVER, IT COULD NOT BE INSERTED INTO THE VESSEL. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL MEDICAL INTERVENTION REPORTED. THE MANUFACTURER'S REPRESENTATIVE CONFIRMED THE FRAY IN THE TIP OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6563554 ↗