Flexor G49100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002491007), received between Jun 8, 2017 and Mar 30, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2023Material Separation; Material Separation

  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 16644780 ↗
• MalfunctionOct 21, 2022Detachment 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15651072 ↗
• MalfunctionJun 30, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, PRIOR TO USE DURING A PROCEDURE INVOLVING ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM, A FLEXOR ANSEL GUIDING SHEATH'S DILATOR WOULD NOT FLUSH. A PHOTO PROVIDED BY THE CUSTOMER SHOWS AN UNKNOWN SUBSTANCE WITHIN THE LUMEN OF THE DILATOR TIP. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14876462 ↗
• MalfunctionSep 20, 2017Break; Break

  A FLEXOR RAABE GUIDING SHEATH WAS USED IN A VENOUS STENTING PROCEDURE IN A FEMORAL VEIN IN THE LEG, VIA CONTRALATERAL APPROACH. IT WAS REPORTED THAT WHEN REMOVING THE CATHETER, IT DAMAGED THE VALVES ON THE SHEATH AND IT CAME APART. IT IS BELIEVED THAT THE CATHETER PULLED THE DIAPHRAGM WHEN IT WAS REMOVED, CAUSING THE SHEATH DAMAGE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. 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 6878677 ↗
• MalfunctionJul 7, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT A MESENTERIC ARTERY STENT PROCEDURE WAS PERFORMED USING A FLEXOR ANSEL GUIDING SHEATH. THE ACCESS SITE WAS THE RIGHT FEMORAL ARTERY WHICH WAS VERY SCARRED. WHEN REMOVING THE 8FR SHEATH, THE HUB POPPED OFF THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693775 ↗
• MalfunctionJun 9, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE TO ADDRESS PERIPHERAL ARTERY OCCLUSIVE DISEASE, THE FLEXOR ANSEL GUIDING SHEATH WITH DILATOR WAS NOT SMOOTH; THE PHYSICIAN COULD NOT INSERT THE FLEXOR INTO THE PATIENT'S VESSELS. DURING INVESTIGATION IT WAS ASCERTAINED THAT THE DISTAL TIP OF THE SHEATH HAD HANGNAIL DAMAGE AND ACCORDION CHARACTERISTICS ALONG WITH SLIGHT HANGNAIL DAMAGE ON THE DILATOR TIP. 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 6629829 ↗
• MalfunctionJun 8, 2017Material Deformation; Material Deformation

  DURING THE INVESTIGATION IS WAS DETERMINED THAT THE DISTAL TIP OF THE FLEXOR ANSEL GUIDING SHEATH TUBING WAS CURLED, STRETCHED, AND HAD HANGNAIL DAMAGE. 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 6623593 ↗