Flexor G12266Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Raabe Modification · Class 2
Quick summary
This Cook Flexor Raabe guiding sheath is a catheter introducer used to place catheters and wires into blood vessels. The 53 reports mostly describe the sheath's outer layer splitting, unraveling or separating — sometimes leaving a piece of it inside the patient, and sometimes leaking fluid or blood. Reports mention 1 death and 12 injuries. No recalls name this device.
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
- 53
- Deaths reported
- 1
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00827002122666), received between Mar 4, 2016 and Jan 13, 2026 — classified as 1 death, 12 injuries, 40 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 Leak7
- Unraveled Material7
- Detachment of Device or Device Component6
- Break5
- Material Split, Cut or Torn3
- Adverse Event Without Identified Device or Use Problem2
- Component Missing2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient12
- No Code Available9
- No Consequences Or Impact To Patient5
- Device Embedded In Tissue or Plaque4
- No Patient Involvement4
- Foreign Body In Patient3
- Death1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2026Detachment of Device or Device Component
AS REPORTED, WHEN FLUSHING THE FLEXOR RAABE GUIDING SHEATH WITH SALINE SOLUTION PRIOR TO AN UNSPECIFIED PROCEDURE, THE SIDE ARM OF THE SHEATH SEPARATED BETWEEN THE PROXIMAL BASE AND THE "SHEATH TUBE". THE PROCEDURE WAS COMPLETED USING ANOTHER UNSPECIFIED NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24057036 ↗MalfunctionOct 27, 2025Unsealed Device Packaging; Unsealed Device Packaging
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391270 ↗MalfunctionOct 6, 2025Break; Break
AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, A FLEXOR RAABE GUIDING SHEATH SPLIT/SEPARATED. PER THE REPORTER, UPON ATTEMPTED REMOVAL OF THE SHEATH OVER AN UNKNOWN WIRE, THE "OUTER LAYER" OF THE SHEATH SPLIT/SEPARATED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23228127 ↗InjuryAug 20, 2025Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 22853678 ↗MalfunctionJul 31, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED; AFTER PUNCTURING THE VESSEL TO ESTABLISH ACCESS DURING AN UNKNOWN PROCEDURE, A HAIR-LIKE FOREIGN OBJECT WAS NOTED ON THE HUB OF A FLEXOR RAABE GUIDING SHEATH WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. 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 22679422 ↗InjuryFeb 20, 2025Break; Break
AS REPORTED, AT THE END OF AN UNSPECIFIED PERIPHERAL PROCEDURE, A FLEXOR RAABE GUIDING SHEATH SEPARATED UPON REMOVAL, LEAVING A PORTION OF THE SHEATH IN THE PATIENT. AN EMERGENT FEMORAL CUT-DOWN WAS PERFORMED, AND THE SHEATH WAS REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE PATIENT WAS NOT HOSPITALIZED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21425800 ↗MalfunctionOct 28, 2024Fluid/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 20544096 ↗MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE INVOLVING THE LEG, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED DURING INSERTION OF THE DEVICE. ACCESS WAS OBTAINED IN THE GROIN FOR A CROSSOVER APPROACH TO TORTUOUS ILIAC VESSELS. AN UNSPECIFIED 45-CENTIMETER COOK ¿CROSSOVER¿ SHEATH WAS INITIALLY USED, BUT DUE TO THE NEED FOR MORE "PUSHABILITY", IT WAS REPLACED WITH THE LONGER COMPLAINT DEVICE. REPORTEDLY, THE ACCESS VESSEL WAS ALSO VERY TORTUOUS; THEREFORE, RESISTANCE WAS ENCOUNTERED UPON INSERTION, AND THE USER HAD TO "TURN QUITE A BIT" TO ADVANCE THE SHEATH TO THE INTENDED LOCATION, AT WHICH POINT THE HUB SEPARATED. ANOTHER MANUFACTURER¿S 0.035-INCH WIRE AND THE DILATOR WERE IN THE SHEATH LUMEN AT THE TIME OF HUB SEPARATION. THE HUB WAS NOT USED TO PULL THE DEVICE FROM THE PATIENT. THE DILATOR AND SHEATH TIPS WERE NOT DAMAGED, AND NO SHARP EDGES WERE NOTED ON THE DEVICE. BECAUSE THE HUB SEPARATED WHEN APPROXIMATELY 35-CENTIMETERS OF THE SHEATH WAS STILL OUTSIDE OF THE BODY, THE SHEATH WAS EASILY REMOVED FROM THE PATIENT. ANOTHER SHEATH WAS ADVANCED OVER THE WIRE GUIDE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301784 ↗MalfunctionJul 23, 2024Fluid/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 19810067 ↗MalfunctionJul 23, 2024Fluid/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 19809961 ↗MalfunctionJul 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE HUB OF THE FLEXOR RAABE GUIDING SHEATH CAME OFF. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19735223 ↗MalfunctionMay 21, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 19364421 ↗MalfunctionMar 8, 2024Fluid/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 18864041 ↗MalfunctionJun 22, 2023Unraveled Material; Detachment of Device or Device Component; Unraveled Material; 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 17183776 ↗InjurySep 16, 2022Break; Unraveled Material; Break; Unraveled Material
AS REPORTED, DURING A PROCEDURE WITHIN THE DISTAL SUPERFICIAL FEMORAL ARTERY, A FLEXOR RAABE GUIDING SHEATH SEPARATED IN HALF UPON REMOVAL FROM THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY AND THE SEPARATED PORTION OF THE DEVICE WAS REMOVED. THE PATIENT REPORTEDLY "DID FINE". PHOTOS OF THE RETURNED COMPLAINT DEVICE SHOW UNRAVELING AND SEPARATION OF THE SHEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 15439745 ↗MalfunctionAug 1, 2022Unraveled Material; Unraveled Material
AS REPORTED, UPON COMPLETION OF AN UNSPECIFIED ANGIOPLASTY PROCEDURE, A FLEXOR RAABE GUIDING SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. THE DEVICE WAS PREPARED AND INSERTED WITHOUT INCIDENT. NO ISSUES WERE NOTED DURING THE PROCEDURE; HOWEVER, RESISTANCE WAS ENCOUNTERED DURING REMOVAL, AND THE SHEATH APPEARED TO BE STUCK IN THE GROIN. THE USER CONTINUED TO PULL THE SHEATH OUT, AT WHICH POINT IT UNRAVELED AND SEPARATED. THE ANATOMY WAS CALCIFIED. PER THE PHYSICIAN, THE PATIENT HAD EXTENSIVE PERIPHERAL ARTERY DISEASE, WHICH (PER THE PHYSICIAN) WAS THE LIKELY CAUSE FOR THE DEVICE BECOMING STUCK, NOT DUE TO PRODUCT ERROR. THE DEVICE WAS SUCCESSFULLY 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 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 15139793 ↗MalfunctionJul 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, PRIOR TO A LOWER LIMB ANGIOPLASTY, A FLEXOR RAABE GUIDING SHEATH'S DILATOR TIP WAS DAMAGED/SPLIT. THIS WAS VERIFIED ON THE INSTRUMENTATION TABLE AND THE DEVICE DID NOT MAKE PATIENT CONTACT. THE DEVICE WAS REPLACED WITH A NEW SAME-TYPE DEVICE, WITHOUT CAUSING ANY HARM TO THE PATIENT. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THAT THE TIP OF THE DILATOR APPEARS TO BE SPLIT. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15042451 ↗MalfunctionApr 11, 2022Break; Break
AS REPORTED, UPON OPENING A FLEXOR RAABE GUIDING SHEATH, IT WAS OBSERVED TO BE BROKEN. THIS WAS NOTED PRIOR TO BEGINNING THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14074598 ↗InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, DURING A RIGHT FEMORAL-POPLITEAL ANGIOGRAM, AN UNKNOWN THICK WHITE SUBSTANCE WAS NOTED ON A FLEXOR RAABE GUIDING SHEATH UPON REMOVAL OF THE DEVICE. THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND SCARRED. THE PATIENT ALSO HAD A HISTORY OF AN AMPUTATION, SEVERE STENOSIS OF THE LEFT FEMORAL AND ILIAC ARTERIES, AND SEVERE DISEASE IN THE RIGHT ILIAC ARTERY AT THE BIFURCATION; THEREFORE, BRACHIAL ACCESS WAS OBTAINED IN THE LEFT ARM TO REACH THE RIGHT ILIAC ARTERY. ADVANCEMENT OF THE SHEATH OVER AN UNSPECIFIED 260-CENTIMETER AMPLATZ WIRE WAS REPORTEDLY SMOOTH UNTIL APPROXIMATELY TWENTY CENTIMETERS, AT WHICH POINT THE PATIENT SCREAMED IN PAIN AND THE SHEATH WOULD NO LONGER ADVANCE. THE SHEATH WAS IN PLACE FOR ONLY A FEW SECONDS AND WAS IMMEDIATELY REMOVED WHEN THE PATIENT REPORTED PAIN. AFTER REMOVAL, A "THICK WHITE LAYER" WAS NOTED ON THE SHEATH. PER THE REPORTER, VESSEL SPASMS WERE NOT NOTED DURING THE PROCEDURE; HOWEVER, THE PATIENT HAD VERY SMALL VESSEL DIAMETERS. HEPARIN, VERAPAMIL, AND FENTANYL WERE GIVEN TO TRY TO ENLARGE THE VESSEL DIAMETERS DURING THE PROCEDURE. THE ANGIOGRAM WAS ABORTED AND THE PATIENT WAS SENT TO SURGERY FOR A BYPASS PROCEDURE. IT SHOULD BE NOTE
Patient problems: Pain
MAUDE report 13053653 ↗MalfunctionAug 4, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING THE ILIAC VEIN VIA ACCESS IN THE FEMORAL VEIN, A FLEXOR RAABE GUIDING SHEATH LEAKED AT THE HEMOSTATIC VALVE. THE SHEATH WAS INSERTED AND ADVANCED TO A LESION WITHIN THE SUPERIOR VENA CAVA WHEN IT BEGAN TO LEAK AT THE VALVE, EVEN WHEN THE VALVE WAS "CLOSED". THE DEVICE WAS REMOVED WITH THE DILATOR BY PULLING ON THE HUB AND THE SHEATH WAS FLUSHED; HOWEVER, THE DEVICE LEAKED AGAIN WHEN IT WAS REINTRODUCED INTO THE PATIENT. THE DEVICE WAS IN PLACE FOR APPROXIMATELY TEN MINUTES. THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. RESISTANCE WAS NOT REPORTED DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND THE PATIENT'S OUTCOME WAS GOOD. 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 12277440 ↗MalfunctionJun 2, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 11919207 ↗MalfunctionMay 3, 2021Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; 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 11759530 ↗MalfunctionDec 1, 2020Material Separation; Material Separation
AS REPORTED, AFTER A RIGHT RADIAL ACCESS PROCEDURE DURING NOVEMBER 2020 AS THE FLEXOR RAABE GUIDING SHEATH WAS BEING REMOVED THE HUB SEPARATED. RESISTANCE WAS NOTED AS THE HUB WAS BEING USED TO REMOVE THE DEVICE FROM THE PATIENT. THE DEVICE WAS REMOVED WHILE A WIRE GUIDE WAS STILL IN THE LUMEN, BUT THE DILATOR WAS NOT WITHIN THE LUMEN. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10928819 ↗MalfunctionDec 1, 2020Material Separation; Material Separation
AS REPORTED, AFTER A RIGHT RADIAL ACCESS PROCEDURE DURING (B)(6) 2020 AS THE FLEXOR RAABE GUIDING SHEATH WAS BEING REMOVED, THE HUB SEPARATED. RESISTANCE WAS NOTED AS THE HUB WAS BEING USED TO REMOVE THE DEVICE FROM THE PATIENT. THE DEVICE WAS REMOVED WHILE A WIRE GUIDE WAS STILL IN THE LUMEN, BUT THE DILATOR WAS NOT WITHIN THE LUMEN. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10928294 ↗MalfunctionDec 1, 2020Packaging Problem; Packaging Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10927990 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.