Flexor G47701Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00827002477018), received between May 22, 2015 and Oct 15, 2025 — classified as 7 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE WHILE "RINSING", THE HUB OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH DETACHED UPON REMOVAL OF THE DILATOR. PER THE REPORTER, THE USER WAS REMOVING THE DILATOR AFTER THE DEVICE HAD BEEN INSERTED INTO THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23281049 ↗
• MalfunctionApr 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR, THE HUB OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH'S DILATOR SEPARATED UPON REMOVAL OF THE DEVICE. THE HUB SEPARATED AFTER THE SHEATH WAS SUCCESSFULLY PLACED IN THE PATIENT VIA THE RIGHT SUBCLAVIAN ARTERY, AND THE DILATOR WAS NO LONGER NEEDED. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. ANOTHER MANUFACTURER'S 0.035-INCH WIRE WAS USED THROUGH THE DEVICE. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH/DILATOR, OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE HUB WAS NOT USED TO PULL THE DILATOR FROM THE PATIENT. 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 DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. DURING THE SAME PROCEDURE, A COOK FENESTRATED GRAFT LEAKED AT THE HUB/VALVE. ANOTHER DEVICE WAS USED TO COMPLETE THAT PORTION OF THE PROCEDURE. REPORTEDLY, THE EVENTS THAT OCCURRED DURING THE PROCEDURE CAUSED AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127958 ↗
• MalfunctionNov 8, 2023Break; Detachment of Device or Device Component; Break; 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 18095865 ↗
• MalfunctionJan 24, 2023Detachment 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 16233814 ↗
• MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE VALVE OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH DISLODGED. THERE HAVE BEEN "NO MAJOR CONSEQUENCES" TO THE PATIENT AS A RESULT OF THIS EVENT. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898938 ↗
• MalfunctionDec 31, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; 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 11100615 ↗
• MalfunctionSep 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING AN ILIAC ANEURYSM, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH LEAKED AT THE VALVE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME. DURING THE SAME PROCEDURE, ANOTHER FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH FROM A DIFFERENT LOT ALSO LEAKED AT THE VALVE. THAT EVENT WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541439 ↗
• MalfunctionSep 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540394 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Seizures

  MAUDE report 9782030 ↗
• MalfunctionMar 8, 2019Detachment of Device or Device Component; Sharp Edges; Detachment of Device or Device Component; Sharp Edges

  DURING PRELIMINARY INVESTIGATION OF THE COMPLAINT DEVICE ON 22 MAR 2019, IT WAS NOTED THE SHEATH WAS KINKED WITH SHARP EDGES. THIS FOLLOW UP REPORT IS SUBMITTED FOR THIS ADDITIONAL FAILURE MODE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405505 ↗
• MalfunctionNov 13, 2018Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED, DURING AN AORTIC STENT GRAFT PROCEDURE THE DILATOR PORTION OF THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH DEVICE BECAME SEPARATED NEAR THE HUB. ACCORDING TO THE INITIAL REPORTER, THE DILATOR WAS IN PLACE WITH AN UNSPECIFIED WIRE GUIDE, OR OTHER DEVICE, INSERTED IN THE LUMEN WHEN THE SEPARATION OCCURRED. HOWEVER, THE SHEATH AND DILATOR WERE NOT WITHDRAWN AS A UNIT. IT WAS PROVIDED THAT NO RESISTANCE WAS FELT DURING THE INSERTION OR REMOVAL PROCESS OF THE DILATOR, AND UPON THE SEPARATION OF THE HUB, THE COMPLAINT DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT'S ANATOMY WITHOUT ISSUE USING CAUTERY FORCEPS. 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 8063427 ↗
• MalfunctionNov 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING AN INFERIOR VENA CAVA (IVC) FILTER RETRIEVAL PROCEDURE, THE HUB OF THE DILATOR PROVIDED WITH THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH DISCONNECTED. ACCORDING TO THE INITIAL REPORTER, ACCESS WAS GAINED VIA THE RIGHT INTERNAL JUGULAR VEIN. THE SHEATH AND DILATOR WERE BEING ADVANCED TOGETHER OVER AN UNSPECIFIED 0.035" WIRE GUIDE. THE PATIENT'S ANATOMY WAS NOT DESCRIBED AS TORTUOUS OR CALCIFIED; HOWEVER, AS THE DILATOR WAS BEING REMOVED OVER THE WIRE GUIDE, IT WAS REPORTED THAT IT WAS BEING REMOVED BY HUB. IT WAS DURING THE REMOVAL THAT THE HUB SEPARATED. THE UNSPECIFIED FILTER DEVICE WAS ABLE TO BE RETRIEVED, 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 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 8053455 ↗
• MalfunctionJan 16, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A WHITE NYLON UNROLLED THREAD WAS HANGING FROM THE END OF THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. THE SHEATH AND THREAD WERE REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. 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 7193188 ↗
• MalfunctionOct 5, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT THE VALVE OF THE INTRODUCER WAS LEAKING WHILE THE WIRE WAS IN PLACE. THE BLOOD LOSS WAS REPORTED TO BE "NOT VERY BIG". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. 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 6916150 ↗
• MalfunctionJul 28, 2017Material Separation; Material Separation

  IT IS ALLEGED THAT A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS BEING OPENED FOR AN EVAR PROCEDURE WHEN IT WAS NOTICED THAT THE FITTING OF THE DILATOR WAS DISCONNECTED. IT WAS REPORTED THAT THE "MANDARIN" FELL OFF WHILE UNWRAPPING THE PRODUCT, BUT IT WAS USED FOR THE PROCEDURE BECAUSE THE CUSTOMER DIDN'T HAVE A SIMILAR ONE IN STOCK. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6752017 ↗
• InjuryJun 22, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A THORACO-ABDOMINAL ANEURYSM REPAIR, A T-BRANCH GRAFT IMPLANT WAS PLACED WITH A 12F HIGH-FLEX ANSEL GUIDING SHEATH INTRODUCER VIA HIGH BRACHIAL CUT DOWN. THE 12F SHEATH VALVE WAS LEAKING / SQUIRTING WITH EACH HEARTBEAT (MANUFACTURERS REPORT NUMBER 1820334-2017-01351) WHILE A COMPETITOR'S 4F CATHETER WAS PLACED OVER A WIRE THROUGH THE VALVE. THE SHEATH WAS REPLACED WITH A SECOND 12F FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, WHICH ALSO HAD SOME LEAKAGE, BUT EVENTUALLY STOPPED (MANUFACTURERS REPORT NUMBER 1820334-2017-01368). THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DOCTOR APPROXIMATED 500CC OF BLOOD LOSS.

  Patient problems: Blood Loss

  MAUDE report 6661117 ↗
• InjuryJun 22, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A THORACO-ABDOMINAL ANEURYSM REPAIR, A T-BRANCH GRAFT IMPLANT WAS PLACED WITH A 12F HIGH-FLEX ANSEL GUIDING SHEATH INTRODUCER VIA HIGH BRACHIAL CUT DOWN. THE 12F SHEATH VALVE WAS LEAKING / SQUIRTING WITH EACH HEARTBEAT (MANUFACTURERS REPORT NUMBER 1820334-2017-01351) WHILE A COMPETITOR'S 4F CATHETER WAS PLACED OVER A WIRE THROUGH THE VALVE. THE SHEATH WAS REPLACED WITH A SECOND 12F FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, WHICH ALSO HAD SOME LEAKAGE, BUT EVENTUALLY STOPPED (MANUFACTURERS REPORT NUMBER 1820334-2017-01368). THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DOCTOR APPROXIMATED 500 CC OF BLOOD LOSS.

  Patient problems: Blood Loss

  MAUDE report 6661081 ↗
• MalfunctionMay 15, 2017Torn Material

  IT WAS REPORTED THAT THE PRODUCT WOULD NOT TURN COMPLETELY. PHOTOS OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE SHEATH WAS DAMAGED AND SLIGHTLY TORN. THE DEVICE WAS USED DURING A PROCEDURE, BUT THERE WAS NO REPORT OF PATIENT INJURY OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6568155 ↗
• MalfunctionMay 11, 2017Material Puncture/Hole; Device Packaging Compromised

  THE COMPLAINANT ALLEGED THAT THE STERILITY OF THE PACKAGE WAS COMPROMISED AS A RESULT OF THE STOP COCK PUNCTURING THROUGH THE PACKAGE . THIS PRODUCT PROBLEM WAS NOTED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6562196 ↗
• MalfunctionMay 11, 2017Device Packaging Compromised

  THE COMPLAINANT ALLEGED THAT THE STERILITY OF THE PACKAGE WAS COMPROMISED AS A RESULT OF THE STOP COCK PUNCTURING THROUGH THE PACKAGE . THIS PRODUCT PROBLEM WAS NOTED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6562089 ↗
• MalfunctionMar 10, 2017Material Separation; Material Separation

  IT WAS REPORTED DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE, THE VASCULAR SURGEON INTRODUCED THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH(SHEATH AND DILATOR). WHEN THE SURGEON WENT TO RETRIEVE THE DILATOR, THE PROXIMAL PART OF THE DILATOR DISCONNECTED. THE VASCULAR SURGEON EXCHANGED THIS FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH OUT FOR ANOTHER ONE WITH A DIFFERENT LOT NUMBER. THERE WERE NO PROBLEMS WITH THE NEW ONE. THE PATIENT WAS UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6396474 ↗
• MalfunctionFeb 22, 2017Material Separation; Material Separation

  THERE WAS NO PATIENT INVOLVED. THE EVENT HAPPENED AT THE PREPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6349119 ↗
• InjuryFeb 16, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED, DURING AN ENDOVASCULAR AORTIC REPAIR, AS SOON AS THIS FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS INSERTED THE VALVE LEAKED BLOOD THROUGHOUT IT'S USE. THE VALVE WAS PLUGGED WITH BOTH THE DILATOR AND ANOTHER 4F DILATOR TO STEM THE BLEEDING. THE PATIENT EXPERIENCED "EXCESSIVE BLOOD LOSS". THE PROCEDURE WAS COMPLETED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: Blood Loss

  MAUDE report 6337169 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. THE ATTENDING PHYSICIAN INDICATED THAT THE TIP OF THE INTRODUCER BROKE OFF AS HE WAS ATTEMPTING TO REMOVE THE DILATOR FROM THE PATIENT. THE ATTENDING PHYSICIAN STATED THE SEPARATION HAPPENED OUTSIDE OF THE PATIENT. THE PATIENT ANATOMY WAS NOT TORTUOUS OR CALCIFIED. NO PIECES FROM THE BROKEN DEVICE WERE LEFT IN THE PATIENT NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS OR MEDICAL INTERVENTION DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6291818 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A BILIARY STONE REMOVAL PROCEDURE, WHILE BEING PLACED THROUGH THE BELLY BUTTON, THE HUB OF A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED FROM THE DILATOR AS IT WAS INSERTED INTO THE SHEATH WHILE THE DILATOR WAS BEING REMOVED. THE PHYSICIAN WAS STILL ABLE TO USE THE DEVICE AND COMPLETED THE PROCEDURE. THE PATIENT WAS UNHARMED AND NO ADDITIONAL PROCEDURES OR INTERVENTION WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6291719 ↗