Flexor G49043Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002490437), received between Jun 21, 2018 and Nov 27, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Detachment 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 20799527 ↗
• MalfunctionNov 10, 2021Material 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 12791914 ↗
• MalfunctionSep 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 08DEC2021: THE DILATOR WAS IN PLACE WHEN THE SEPARATION OCCURRED. IT IS PRESUMED THAT THERE WAS A WIRE IN THE LUMEN OF THE SHEATH WHEN THE SEPARATION OCCURRED. THE SHEATH HUB WAS NOT USED TO PULL THE DEVICE FROM THE PATIENT. THE DEVICE WAS INSIDE OF THE PATIENT WHEN THE SEPARATION OCCURRED. THERE WERE NO SHARP EDGES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408112 ↗
• MalfunctionJul 28, 2021Break; Material Separation; Break; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 24SEP2021. THE PATIENT LOST AN ESTIMATED 20ML BLOOD DURING THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238602 ↗
• MalfunctionAug 19, 2020Material Separation; Stretched; Material Separation; Stretched

  AS REPORTED, PRIOR TO USE, AS THE DOCTOR WAS ATTEMPTING TO SHAPE THE DEVICE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH STRETCHED AND "RIPPED" AT THE SHAFT, EXPOSING THE COILS OF THE DEVICE. THE DILATOR WAS IN PLACE AT THE TIME OF THE EVENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE, AN ANGIO OF THE RIGHT LEG, SUCCESSFULLY. 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 10427182 ↗
• MalfunctionJul 21, 2020Peeled/Delaminated; Peeled/Delaminated

  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 10301483 ↗
• MalfunctionMar 26, 2020Fluid/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 9884499 ↗
• MalfunctionMar 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED AT THE HUB DURING REPOSITIONING OF THE DEVICE. AN UNKNOWN GUIDE WIRE WAS IN THE LUMEN OF THE DEVICE WHEN THE HUB SEPARATED. NORMAL RESISTANCE WAS REPORTED AS THE SHEATH WAS MOVED OVER THE CALCIFIED AORTIC BIFURCATION. 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 9781404 ↗
• MalfunctionJan 24, 2019Material 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 Consequences Or Impact To Patient

  MAUDE report 8274966 ↗
• InjuryJun 21, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING RECANALIZATION OF THE PATIENT'S CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), THE TIP OF THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH BROKE AND BECAME LODGED IN THE PATIENT'S ANATOMY. AN INCISION WAS MADE IN THE PATIENT'S LEG IN ORDER TO RETRIEVE THE SEPARATED PORTION OF THE COMPLAINT DEVICE. THE RETRIEVAL WAS SUCCESSFUL AND THE PATIENT REPORTEDLY WAS "OK" AFTER THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE AFTER THE RETRIEVAL OF THE BROKEN DEVICE COMPONENT.

  Patient problems: No Code Available

  MAUDE report 7625473 ↗