Flexor G56279Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002562790), received between Jun 13, 2016 and Sep 14, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 26, 2025Open, Classified

   Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

   Z-0993-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE DILATOR HUBS SEPARATED FROM TWO FLEXOR HIGH-FLEX ANSEL GUIDING SHEATHS. REPORTEDLY, AFTER INSERTING THE SHEATH AND DILATOR, THE "INJECTION PIECE" BROKE WHEN THE USER PULLED THE DILATOR FROM THE SHEATH. THE DILATORS WERE REMOVED WITH A CLAMP. 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 17745524 ↗
• MalfunctionDec 29, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 11086831 ↗
• MalfunctionDec 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 10959171 ↗
• MalfunctionJan 24, 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 Known Impact Or Consequence To Patient

  MAUDE report 8273861 ↗
• MalfunctionMar 23, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS LEAKING. 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 7367068 ↗
• MalfunctionJan 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH A ZENITH BIFURCATED ILIAC SIDE (ZBIS) STENT GRAFT, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH VALVE WAS LEAKING BLOOD/ HAD POOR HEMOSTASIS. THE ACCESS SITE UTILIZED DURING THE PROCEDURE WAS THE PATIENT'S GROIN; A WIRE GUIDE AND 5 FR CATHETER WERE BEING USED THROUGH THE SHEATH AT THE TIME OF THE EVENT. THE PATIENT'S BLOOD WAS CONSISTENTLY DRIPPING; HOWEVER, NO INTERVENTION WAS REQUIRED AS A RESULT. THIS EVENT WAS NOTED TO HAVE OCCURRED WITH THE SAME PRODUCT AND LOT ON SEPARATE OCCASIONS (REFER TO MEDWATCH 1820334-2018-00136). 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 7184212 ↗
• MalfunctionJan 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH A ZENITH BIFURCATED ILIAC SIDE (ZBIS) STENT GRAFT, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH VALVE WAS LEAKING BLOOD/ HAD POOR HEMOSTASIS. THE ACCESS SITE UTILIZED DURING THE PROCEDURE WAS THE PATIENT'S GROIN; A WIRE GUIDE AND 5 FR CATHETER WERE BEING USED THROUGH THE SHEATH AT THE TIME OF THE EVENT. THE PATIENT'S BLOOD WAS CONSISTENTLY DRIPPING; HOWEVER, NO INTERVENTION WAS REQUIRED AS A RESULT. THIS EVENT WAS NOTED TO HAVE OCCURRED WITH THE SAME PRODUCT AND LOT ON SEPARATE OCCASIONS (REFER TO MEDWATCH 1820334-2018-00137). 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 7184109 ↗
• InjurySep 5, 2017Detachment Of Device Component; Detachment Of Device Component

  A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS USED IN AN ENDOVASCULAR AORTIC ANEURYSM REPAIR PROCEDURE VIA IPSILATERAL APPROACH. IT WAS REPORTED THAT, THE SHEATH WAS INSERTED INTO THE PATIENT AND THE HUB OF THE DILATOR SEPARATED. CLAMPS WERE USED TO REMOVE THE DILATOR AND ANOTHER DILATOR WAS INSERTED INTO THE SHEATH TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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 Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6842810 ↗
• MalfunctionJun 22, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT A FLEXOR HIGH FLEX ANSEL GUIDING SHEATH WAS USED FOR A THORACAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR. THE DEVICE WAS INTRODUCED IN THE USUAL FASHION. UPON REMOVAL OF THE DILATOR, THE DILATOR HUB SEPARATED FROM THE DILATOR ITSELF. THE END USER WAS ABLE TO GRAB THE DILATOR AND REMOVE IT SAFELY. THE DILATOR AND HUB COMPONENTS WERE SAVED FOR RETURN AND EVALUATION. THE SHEATH WAS ALREADY IN WHEN THE DILATOR BROKE. THE PROCEDURE WAS FINISHED WITH THIS SHEATH. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6661053 ↗
• MalfunctionMay 3, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE USING A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, THE HUB OF THE DILATOR FELL OFF WITH MINIMAL MANIPULATION DURING THE PREPPING PROCESS FOR THE DEVICE. THIS OCCURRED AWAY FROM THE PATIENT. ANOTHER FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6541768 ↗
• MalfunctionSep 6, 2016Material Separation; Material Separation

  THE HUB OF THE DILATOR SEPARATED FROM THE DILATOR. THE DILATOR WAS SUCCESSFULLY REMOVED BY HAND WITH NO SUBSEQUENT INTERVENTION. THE PROCEDURE WAS COMPLETED WITH THE DEVICE IN QUESTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5930385 ↗
• MalfunctionJun 13, 2016Material Separation; Material Separation

  DURING A FILTER REMOVAL PROCEDURE, THE HUB DETACHED FROM THE 12FR GUIDING SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5719963 ↗