Flexor G49045Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002490451), received between Mar 25, 2016 and Nov 12, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 12, 2025Detachment 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 23533437 ↗
• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ¿AORTIC CASE¿, THE HUB/VALVE OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH BROKE OFF WHILE FLUSHING THE DEVICE. A COOK ¿1CM¿ 260-CENTIMETER AMPLATZ WIRE AND COOK 12-FRENCH FLEXOR SHEATH WERE ALSO USED DURING THE PROCEDURE. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH, OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE HUB WAS NOT USED TO PULL THE DEVICE FROM THE PATIENT, THE DILATOR WAS NOT REINSERTED PRIOR TO SHEATH REMOVAL, AND NOTHING WAS IN THE SHEATH LUMEN WHEN THE HUB SEPARATED. THE DEVICE WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 23424066 ↗
• InjuryOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ILIAC BRANCH IMPLANTATION PROCEDURE INVOLVING PLACEMENT OF ANOTHER MANUFACTURER¿S STENT INTO THE INTERNAL ILIAC ARTERY, THE HUB OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED FROM THE DEVICE. CONTRALATERAL ACCESS WAS OBTAINED, AND AN UNSPECIFIED COOK 12-FRENCH ANSEL SHEATH WAS PLACED UP-AND-OVER THE BIFURCATION. THE ANATOMY WAS REPORTEDLY ANGULATED AND VERY TORTUOUS OVER THE BIFURCATION. CALCIFICATION WAS NOT NOTED. THE 8-FRENCH COMPLAINT DEVICE WAS EASILY INSERTED AND ADVANCED COAXIALLY, OVER AN UNSPECIFIED AMPLATZ WIRE GUIDE, THROUGH THE 12-FRENCH SHEATH. ANOTHER MANUFACTURER¿S STENT DELIVERY SYSTEM WAS EASILY INSERTED AND ADVANCED THROUGH THE COMPLAINT DEVICE, OVER THE WIRE. AFTER THE STENT WAS POSITIONED IN THE INTERNAL ILIAC ARTERY, THE USER ATTEMPTED TO PULL THE COMPLAINT DEVICE BACK TO DEPLOY THE STENT, USING THE HUB TO PULL THE SHEATH. PER THE REPORTER, ¿EVERYTHING WAS TIGHT¿ AND THE INTERNAL ILIAC ARTERY WAS VERY ANGULATED; THEREFORE, THE PHYSICIAN HAD TO USE ¿AN EXCESSIVE AMOUNT OF FORCE¿ TO PULL THE SHEATH BACK, AT WHICH POINT THE HUB SEPARATED, RESULTING IN ¿A LOT¿ OF BLOOD LOSS. THE STENT WAS QUICKLY DEPLOYED, AND THE COMPLAINT DEVICE WAS R

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20536759 ↗
• MalfunctionMay 21, 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 19360427 ↗
• InjuryJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 28JUN2023. THE COMPLAINT DEVICE AND ANOTHER MANUFACTURER¿S SHEATH WERE PLACED INSIDE OF A 12FRENCH COOK SHEATH AT THE SAME TIME, BY PUNCTURING THE VALVE OF THE 12 FRENCH SHEATH. THE SHEATH HUB WAS USED TO PULL THE DEVICE FROM THE PATIENT. THE DILATOR WAS NOT REINSERTED INTO THE SHEATH PRIOR TO REMOVAL, AS THE ROSEN WIRE AND OTHER MANUFACTURER¿S STENT WERE STILL IN THE LUMEN OF THE SHEATH. THE SHEATH WAS REMOVED WITH A CLAMP. THE PATIENT REQUIRED UNSPECIFIED TREATMENT FOR BLOOD LOSS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17173207 ↗
• MalfunctionMar 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING RETROGRADE ACCESS OF THE RIGHT ILIAC ARTERY UP-AND-OVER THE AORTIC BIFURCATION, THE HUB SEPARATED FROM A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. THE DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY AND ADVANCED OVER THE AORTIC BIFURCATION INTO THE RIGHT ILIAC ARTERY OVER ANOTHER MANUFACTURER'S WIRE GUIDE. THE ILIAC VESSELS WERE TORTUOUS, AND THE USER FELT RESISTANCE DURING ADVANCEMENT. THE SHEATH WAS IN PLACE FOR APPROXIMATELY 30 MINUTES. AS THE DEVICE WAS PULLED BY THE HUB TO BE REMOVED OVER A ROSEN WIRE GUIDE, RESISTANCE WAS AGAIN FELT, AND THE HUB SEPARATED FROM THE SHAFT OF THE DEVICE AFTER ADDITIONAL FORCE WAS USED TO ENABLE REMOVAL. THE DILATOR WAS NOT IN PLACE AS THE DEVICE WAS REMOVED. NO PART OF THE DEVICE REMAINED IN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT OUTCOME WAS "GOOD." THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772976 ↗
• MalfunctionJan 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY, THE HUB SEPARATED FROM A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH UPON REMOVAL OF AN UNSPECIFIED CATHETER THROUGH THE SHEATH. ANOTHER FLEXOR SHEATH OF A DIFFERENT SIZE AND TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 13258388 ↗
• MalfunctionJul 24, 2020Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND A CROSS-OVER APPROACH WAS USED. ANOTHER MANUFACTURER'S CATHETER WAS PLACED WITHIN THE COMPLAINT DEVICE. THE PATIENT WAS REPORTEDLY STABLE. THE ANATOMY WAS SLIGHTLY CALCIFIED AT THE COMMON ILIAC ARTERY. THE DILATOR WAS NOT IN PLACE AT THE TIME OF HUB SEPARATION; HOWEVER, A WIRE GUIDE WAS IN PLACE. THE PHYSICIAN DESCRIBED "NORMAL" RESISTANCE. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321486 ↗
• MalfunctionJun 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 10106992 ↗
• MalfunctionMay 14, 2020Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, PRIOR TO USE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH PACKAGE WAS FOUND TO BE INCOMPLETELY SEALED. THE DEVICE WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 10057673 ↗
• MalfunctionMar 26, 2020Material Separation; Material Separation

  THE DEVICE PACKAGE WAS NOT DAMAGED, AND THE DEVICE WAS STORED "AS USUAL".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884440 ↗
• MalfunctionAug 2, 2019Detachment 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 8854994 ↗
• MalfunctionFeb 19, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH HEMOSTATIC VALVE DISCONNECTED FROM THE SHEATH. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280526 ↗
• MalfunctionAug 30, 2017Material Separation; Material Separation

  A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS USED IN AN UNSPECIFIED PROCEDURE. UPON RECEIPT OF THE RETURNED PRODUCT, IT WAS NOTED THE HUB IS SEPARATED FROM THE SHEATH. NO OTHER INFORMATION HAS BEEN PROVIDED. PATIENT AND PROCEDURAL INFORMATION HAVE BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6830646 ↗
• MalfunctionAug 22, 2017Torn Material; Torn Material

  A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS USED IN AN UNSPECIFIED PROCEDURE IN THE LEG. IT WAS REPORTED, DURING REMOVAL FROM CALCIFIED ANATOMY, THE TIP OF THE CATHETER WAS TORN. IT HAS BEEN DOCUMENTED THAT 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 6810590 ↗
• MalfunctionMay 12, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE USING A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, THE SHEATH AND VALVE WERE SEPARATED DURING PREPARATION FOR THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EVENT RELATED TO THE SEPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6563198 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  INTERNATIONAL CUSTOMER REPORTED THAT VALVE LOOSENED AND SEPARATED FROM THE SHEATH. THIS OCCURRED WHEN INTRODUCING THE DILATOR IN THE SHEATH PRIOR TO PATIENT CONTACT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6291708 ↗
• MalfunctionMar 25, 2016Material Separation; Material Separation

  DURING A PROCEDURE FOR PERIPHERAL ARTERY OCCLUSION DISEASE, LEFT LEG OF THE (B)(6) YEAR OLD MALE PATIENT, THE HUB AND SHAFT SEPARATED WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE OUTCOME OF THE PATIENT REPORTED TO HAVE BEEN GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5527052 ↗