Flexor G48192Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002481923), received between Mar 5, 2019 and Dec 23, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionDec 23, 2025Break; Break

  AS REPORTED, DURING PREPARATION FOR A PROCEDURE INVOLVING REVASCULARIZATION OF THE MESENTERIC ARTERY, THE DILATOR WOULD NOT FIT INTO A FLEXOR ANSEL GUIDING SHEATH. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND ANOTHER SYSTEM WAS USED. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH SHAFT MATERIAL WAS SEPARATED INSIDE THE HUB. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877542 ↗
• MalfunctionJan 27, 2022Unraveled Material; Unraveled Material

  AS REPORTED, DURING REMOVAL OF A 5FR 110CM FLEXOR ANSEL GUIDING SHEATH, THE SHEATH SEPARATED ALONG THE SHAFT EXPOSING THE INNER WIRE COILS. IT WAS NOTED THAT THE DEVICE DID NOT COMPLETELY SEPARATE, BUT IT DID UNRAVEL. THE SHEATH WAS BEING REMOVED OVER A WIRE WHEN THE MALFUNCTION OCCURRED. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367884 ↗
• MalfunctionMar 5, 2020Crack; Crack

  AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE, THE PLASTIC TUBING OF A FLEXOR ANSEL GUIDING SHEATH WAS FOUND TO BE CRACKED AND THE SHEATH APPEARED CRIMPED. THE PROCEDURE WAS INSTEAD COMPLETED WITH A COOK 6 FRENCH, 90 CENTIMETER ANSEL SHEATH. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT. THE DEVICE WAS STORED HANGING ON A RACK IN THE PROCEDURE ROOM. THERE WAS NO DAMAGE TO THE PACKAGE NOTED. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793013 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Abscess

  MAUDE report 8391235 ↗