Flexor G29982Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Ansel Modification · Class 2
Quick summary
This Cook Flexor introducer sheath is used to guide catheters and wires into blood vessels during procedures such as angiograms and angioplasties. Most of the 62 reports describe the sheath coming apart, fraying or splitting while in the patient or before use, plus leaks and broken hubs; several mention blood loss. No deaths were reported, but 18 injuries were. There are no recalls naming this device, and no reports were filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 62
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00827002299825), received between Jul 29, 2016 and Sep 16, 2025 — classified as 18 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Material Separation” (17 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.
Reports received per month
Most reported problems
Device problems
- Material Separation17
- Fluid/Blood Leak8
- Break7
- Peeled/Delaminated6
- Detachment of Device or Device Component5
- Unraveled Material5
- Material Split, Cut or Torn4
- Difficult to Remove3
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient15
- No Code Available11
- No Consequences Or Impact To Patient11
- Insufficient Information4
- Blood Loss3
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2025Break; Unraveled Material; Break; Unraveled Material
AS REPORTED, DURING AN "AORTOGRAM WITH RUNOFF" PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH CAME APART AND UNRAVELED IN THE PATIENT. THE DEVICE WAS CAUGHT ON PLAQUE IN THE BIFURCATION. THE DEVICE AS A WHOLE WAS REMOVED FROM THE PATIENT. 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 THE OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23065046 ↗MalfunctionJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, IN THE MIDDLE OF AN UNKNOWN PROCEDURE, THE HUB BROKE OFF OF A FLEXOR ANSEL GUIDING SHEATH. THE SHEATH WAS REPLACED. 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 22330098 ↗MalfunctionMay 2, 2025Break; Break
AS REPORTED, DURING AN ANGIOGRAM AND ANGIOPLASTY OF THE LEFT LEG, A FLEXOR ANSEL GUIDING SHEATH SEPARATED WHILE IN THE PATIENT. THE DEVICE HAD BEEN IN USE FOR ONE-TO-TWO HOURS AT THE TIME OF SEPARATION. THE CUSTOMER REPORTED A ¿NEAR MISS.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21952059 ↗MalfunctionNov 14, 2024Unsealed Device Packaging; Unsealed Device Packaging
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 20682712 ↗MalfunctionMar 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED 13MAR2024. AN UNSPECIFIED STIFF .014 WIRE GUIDE WAS USED IN THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER MANUFACTURER'S SHEATH. THE PATIENT DID NOT REQUIRE TREATMENT FOR ANY BLOOD LOSS. THERE WAS NOT ANY UNINTENDED SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18840760 ↗MalfunctionNov 14, 2023Break; Break
AS REPORTED, PRIOR TO PATIENT CONTACT FOR AN UNKNOWN PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH'S LUER-LOCK FITTING WAS FOUND TO BE BROKEN AS THE USER ATTEMPTED TO FLUSH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT INCIDENT. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 18130484 ↗MalfunctionOct 23, 2023Fluid/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 Clinical Signs, Symptoms or Conditions
MAUDE report 17987365 ↗MalfunctionMay 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, UPON OPENING AND INSPECTING THE DEVICE, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH'S DILATOR WAS DAMAGED AND APPEARED TO BE CUT. THE DEVICE WAS NOT USED, AND A NEW SHEATH WAS USED TO COMPETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. PHOTOS PROVIDED BY THE CUSTOMER SHOW WHAT APPEARS TO BE A CUT/SPLIT/TEAR IN THE DILATOR TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16863097 ↗MalfunctionFeb 17, 2023Peeled/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 Clinical Signs, Symptoms or Conditions
MAUDE report 16400571 ↗MalfunctionFeb 2, 2023Peeled/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 Clinical Signs, Symptoms or Conditions
MAUDE report 16283660 ↗MalfunctionJan 4, 2023Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn
UPON ADDITIONAL EVALUATION OF THE DEVICE, THE SHEATH WAS FOUND TO BE DELAMINATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16098165 ↗MalfunctionJan 4, 2023Break; Break
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 16095317 ↗InjuryOct 24, 2022Break; Difficult to Remove; Unraveled Material; Break; Difficult to Remove; Unraveled Material
AS REPORTED, DURING AN AEL PROCEDURE OF THE LEFT ILIAC AND FEMORAL ARTERIES VIA CONTRALATERAL ACCESS FROM THE RIGHT FEMORAL ARTERY, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED. THE SHEATH BECAME STUCK, AND THE PHYSICIAN USED FORCE TO REMOVE IT, AT WHICH POINT THE SHEATH UNRAVELED AND SEPARATED. A FRAGMENT INCLUDING THE RADIOPAQUE BAND REMAINED IN THE PATIENT AND WAS THEREFORE STENTED AGAINST THE ARTERY WALL. AN OPEN SURGICAL PROCEDURE WAS PERFORMED ON THE RIGHT FEMORAL ACCESS SITE TO REPAIR THE ARTERIAL DAMAGE THAT OCCURRED DURING REMOVAL OF THE SHEATH. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 15663167 ↗MalfunctionAug 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN ANGIOGRAM OF THE LEFT LOWER EXTREMITY VIA ACCESS IN THE RIGHT GROIN, A FLEXOR ANSEL GUIDING SHEATH SEPARATED AT THE HUB WHILE THE SHEATH WAS IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15229813 ↗MalfunctionJan 4, 2022Stretched; Unraveled Material; Stretched; Unraveled Material
AS REPORTED, DURING A PROCEDURE INVOLVING A STENOSED SUPERFICIAL FEMORAL ARTERY, A FLEXOR ANSEL GUIDING SHEATH STRETCHED. AFTER ARTERIAL ACCESS WAS OBTAINED, THE SHEATH WAS REPORTEDLY DIFFICULT TO ADVANCE OVER AN UNKNOWN HYDROPHILICALLY-COATED WIRE GUIDE DUE TO "FIBROSIS IN THE SCARPA". AN UNKNOWN CATHETER AND BALLOON WERE PLACED THROUGH THE SHEATH. AFTER THE BALLOON WAS DEFLATED, IT WAS REPORTEDLY DIFFICULT TO REMOVE FROM THE SHEATH, WHICH SUBSEQUENTLY ELONGATED FIVE CENTIMETERS FROM THE TIP. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT OVER THE WIRE GUIDE. ANOTHER SHEATH WAS THEN USED TO SUCCESSFULLY COMPLETE THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENT PLACEMENT 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 TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13156429 ↗MalfunctionSep 29, 2021Leak/Splash; Leak/Splash
AS REPORTED, DURING AN UNKNOWN PROCEDURE A FLEXOR ANSEL GUIDING SHEATH WAS LEAKING FROM THE VALVE AND THEY COULD NOT STOP THE BLEEDING. IT IS CURRENTLY UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12547214 ↗MalfunctionAug 13, 2021Fluid/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: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12319333 ↗MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12239084 ↗MalfunctionJul 27, 2021Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED 14SEP2021. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY. AN UNSPECIFIED BENTSON WIRE WAS USED FOR INSERTION OF THE DEVICE. RESISTANCE WAS NOT ENCOUNTERED. THE SHEATH WAS IN PLACE FOR ONE-TO-THREE MINUTES. BLOOD LOSS WAS NOT SIGNIFICANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12233052 ↗MalfunctionJul 19, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE ENTIRE SHEATH WAS NOTED TO BE SEPARATED FROM THE HUB OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12189131 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12016875 ↗MalfunctionApr 7, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11631050 ↗MalfunctionFeb 22, 2021Detachment 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 11359583 ↗MalfunctionNov 12, 2020Peeled/Delaminated; Peeled/Delaminated
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10828310 ↗MalfunctionOct 1, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, DURING AN UNKNOWN PROCEDURE, TWO FLEXOR ANSEL GUIDING SHEATHS WERE FOUND TO BE DEFECTIVE UPON OPENING THE DEVICE PACKAGING. A PHOTO PROVIDED BY THE CUSTOMER SHOWS WHAT APPEARS TO BE A SPLIT OR CUT ON THE END OF ONE DEVICE. THE "FLAW" WAS NOTICED PRIOR TO INSERTION OF THE DEVICES INTO THE PATIENT. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10613804 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.