Flexor G49099Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002490994), received between Nov 14, 2016 and Aug 4, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• MalfunctionAug 4, 2021Material Separation; Unraveled Material; Detachment of Device or Device Component; Material Separation; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, DURING AN ENDOVASCULAR ANEURYSM REPAIR INVOLVING A MALE PATIENT BETWEEN (B)(6) YEARS OF AGE, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED. THE DEVICE WAS REPORTEDLY DIFFICULT TO REMOVE, AND THE BACK END OF THE SHEATH SEPARATED UNDER EXPECTED TENSION AND THEN BEGAN TO UNRAVEL. THE USER REPORTED THAT THE AORTIC ARCH WAS TIGHT AND THE PHYSICIAN ALSO EXPERIENCED DIFFICULTY ADVANCING AN UNKNOWN ILIAC BRANCH GRAFT OVER THE TIGHT BIFURCATION. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE, WHICH WAS REPORTEDLY EXTENDED BY FIVE MINUTES. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12274088 ↗
• MalfunctionMar 1, 2021Fitting Problem; Detachment of Device or Device Component; Fitting Problem; 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 11395141 ↗
• MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 05FEB2021. THE PATIENT HAD PERIPHERAL ARTERY DISEASE. RETROGRADE ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY TO TARGET THE SUPERFICIAL FEMORAL ARTERY. RESISTANCE WAS NOT MET DURING INSERTION OR REMOVAL OF THE DEVICE VIA THE "CLEAN" ACCESS SITE. THE DILATOR WAS NOT IN PLACE AT THE TIME OF THE EVENT AND THE DEVICE WAS BARELY ADVANCED INTO THE SITE. AFTER THE SIDE-ARM DETACHED, THE SHEATH AND DILATOR WERE REMOVED AS A UNIT, WITH THE WIRE GUIDE IN PLACE, BY PULLING BOTH THE SHEATH AND HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11245368 ↗
• MalfunctionAug 3, 2020Detachment 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 10356914 ↗
• MalfunctionMay 3, 2019Fluid/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 Consequences Or Impact To Patient

  MAUDE report 8579290 ↗
• MalfunctionJul 27, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT A FLEXOR ANSEL GUIDING SHEATH WAS BEING USED FOR AN EMBOLECTOMY WHEN THE "SIDE ARM" AND HUB SEPARATED FROM THE SHEATH. THE DEVICE WAS INSERTED IN THE FEMORAL ARTERY IN THE GROIN REGION, AND ANOTHER MANUFACTURER'S DEVICE WAS BEING USED WITHIN THE SHEATH. THE DEVICE BEGAN TO SEPARATE UPON REMOVAL, AND THE DILATOR WAS REINSERTED TO SUCCESSFULLY REMOVE THE SHEATH FROM THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6746734 ↗
• InjuryNov 14, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT THE INTRODUCER WAS USED FOR A ROTAREX PROCEDURE AND HAD TO BE REMOVED COMPLETELY BECAUSE THE INTRODUCER WAS BROKEN. THE PATIENT HAD A LOT OF BLOOD LOSS BECAUSE AFTER THE REMOVAL OF THE ROTAREX THAT THE WIRE THE PROCEDURE HAD TO BE REPEATED. REPORTEDLY IN THE END ¿EVERYTHING WAS WELL FOR THE PATIENT.¿ NEW INFORMATION FROM THE MANUFACTURER'S QUALITY ENGINEER DETERMINED THIS COMPLAINT TO BE REPORTABLE UPON REVIEW OF THE RETURNED COMPLAINT DEVICE. 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: Blood Loss

  MAUDE report 6100143 ↗