Flexor G11638Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00827002116382), received between May 26, 2016 and Sep 30, 2026 — classified as 24 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Material Separation” (31 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break

  As reported, during an angiogram of the right leg, a FLEXOR RAABE GUIDING SHEATH separated. Per the reporter, while pulling the sheath out of the patient, the sheath's hub separated and then the sheath unraveled and "broke" in the middle, becoming stuck in the patient's groin. The dilator was not reinserted prior to attempted removal of the sheath. Reportedly, the user was able to retrieve the broken parts of the sheath, which added approximately one hour to the 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 event.Additional information has been requested but is not available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945260 ↗
• MalfunctionFeb 25, 2026Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 24MAR2026. CONTRALATERAL ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE ANATOMY, INCLUDING THE ACCESS SITE, WAS VERY CALCIFIED AND THE AORTIC BIFURCATION WAS TIGHT. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE DEVICE. THE SHEATH WAS REMOVED WITHOUT ANY ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445937 ↗
• MalfunctionMay 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AT THE END OF A LOWER LEG ANGIOGRAM WITH INTERVENTION, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED AS THE SHEATH WAS PULLED BACK OVER THE BIFURCATION. REPORTEDLY, ANTEGRADE ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY. THE ACCESS SITE WAS SCARRED. OTHER MANUFACTURERS¿ BALLOONS, EMBOLIC PROTECTION DEVICE, AND ATHERECTOMY DEVICE WERE USED THROUGH THE SHEATH DURING THE PROCEDURE, AS WELL AS A COOK BALLOON CATHETER. RESISTANCE WAS ENCOUNTERED DURING INSERTION AND REMOVAL OF THE SHEATH, AS WELL AS DURING INSERTION AND REMOVAL OF OTHER DEVICES THROUGH THE SHEATH. THE HUB WAS NOT USED TO PULL THE SHEATH FROM THE PATIENT, AND THE DILATOR WAS REINSERTED PRIOR TO SHEATH REMOVAL. AFTER THE HUB SEPARATED, THE SHEATH SHAFT WAS MANUALLY REMOVED 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952959 ↗
• MalfunctionMar 14, 2025Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE VIA CONTRALATERAL ACCESS IN THE GROIN, A FLEXOR RAABE GUIDING SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE ANATOMY WAS TORTUOUS AND CALCIFIED, AND THE BIFURCATION WAS MODERATELY STEEP. MINIMAL RESISTANCE WAS REPORTED UPON INSERTION AND ADVANCEMENT OF THE SHEATH. OTHER MANUFACTURERS¿ BALLOONS AND CATHETERS WERE USED THROUGH THE SHEATH, AS WELL AS ANOTHER MANUFACTURER¿S STIFF ANGLED WIRE GUIDE. RESISTANCE WAS ENCOUNTERED UPON ATTEMPTED REMOVAL OF THE SHEATH, AT WHICH POINT THE SHEATH BEGAN TO UNRAVEL. PER THE REPORTER, THE USER THEN ATTEMPTED TO REINSERT THE DILATOR WITH A STIFF WIRE GUIDE; HOWEVER, THE USER WAS STILL UNABLE TO REMOVE THE SHEATH, WHICH SEPARATED. ACCESS WAS OBTAINED IN THE OPPOSITE GROIN, AND A SNARE WAS USED TO PULL THE SEPARATED DEVICE THROUGH AN UNSPECIFIED 11-FRENCH SHEATH. 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH WAS UNRAVELED AND SEPARATED, AND TIP DAMAGE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607092 ↗
• MalfunctionJul 16, 2024Unraveled Material; Unraveled Material

  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 19752478 ↗
• MalfunctionJun 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 14JUN2024. THE ANATOMY WAS MODERATELY TORTUOUS, AND CONTRALATERAL APPROACH WAS USED. AN UNSPECIFIED STIFF WIRE WAS USED DURING THE PROCEDURE. PER THE REPORTER, RESISTANCE WAS FELT DURING INSERTION AND REMOVAL OF THE COMPLAINT DEVICE, AND UPON ADVANCING/REMOVING AN UNSPECIFIED DEVICE THROUGH THE SHEATH. THE SHEATH WAS REMOVED "MANUALLY", AND THE PROCEDURE WAS COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536998 ↗
• MalfunctionMay 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 19339918 ↗
• InjuryMay 6, 2024Break; Unraveled Material; Detachment of Device or Device Component; Break; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY, A FLEXOR RAABE GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY TO TARGET THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE, AS THE ANATOMY WAS HEAVILY SCARRED, AND THE PHYSICIAN REPORTEDLY HAD ¿TROUBLE¿ WITH THE ACCESS SITE. RESISTANCE WAS ALSO ENCOUNTERED UPON REMOVAL OF THE SHEATH, AT WHICH POINT THE SHEATH ¿STARTED SHREDDING¿ AND THE HUB ALSO SEPARATED. REPORTEDLY, THE USER PULLED THE SHEATH BY THE HUB DURING REMOVAL. A COOK 300-CENTIMETER WIRE WAS USED FOR SHEATH REMOVAL AND WAS IN THE SHEATH LUMEN AT THE TIME OF SEPARATION. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH, AND REPORTEDLY, THE SHEATH BEGAN TO SEPARATE BEFORE THE DILATOR COULD BE USED. A CUT-DOWN OF THE COMMON FEMORAL ARTERY WAS PERFORMED TO REMOVE THE SEPARATED SHEATH FRAGMENTS, AND THE ARTERY WAS REPAIRED WITH A PATCH AND STITCHES. THE PHYSICIAN LATER MENTIONED THAT HE SHOULD HAVE USED THE DILATOR AND A STIFFER WIRE DURING REMOVAL OF THE SHEATH. NO PART OF THE DEVICE REMAINED IN THE PATIENT. ACCORDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19254910 ↗
• MalfunctionAug 29, 2023Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE. REPORTEDLY, A "LOT" OF RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE INTO THE PATIENT'S GROIN. THE ANATOMY WAS HEAVILY CALCIFIED, BUT OTHERWISE NORMAL. THE SEPARATED PORTION OF THE DEVICE WAS SNARED FROM THE PATIENT THROUGH A 10-FRENCH SHORT SHEATH. A PHOTO OF THE DEVICE, PROVIDED BY THE CUSTOMER, SHOWS SEPARATION OF THE SHEATH MATERIAL. THE INTERNAL COILS ARE UNRAVELED AND PROTRUDING FROM THE PROXIMAL SHEATH FRAGMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644075 ↗
• InjuryJun 12, 2023Break; 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 17108106 ↗
• MalfunctionMay 1, 2023Break; Unraveled Material; Detachment of Device or Device Component; Break; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM VIA CONTRALATERAL ACCESS IN A SCARRED RIGHT GROIN, A FLEXOR RAABE GUIDING SHEATH UNRAVELED AND SEPARATED AT THE HUB AND SHAFT. THE ANATOMY, INCLUDING THE AORTIC BIFURCATION, WAS VERY CALCIFIED. RESISTANCE WAS ENCOUNTERED UPON INSERTION AND REMOVAL OF THE SHEATH. REPORTEDLY, THE DOCTOR TOUCHED THE SHEATH AND THE HUB FELL OFF. THE SHEATH THEN REPORTEDLY KINKED AND SEPARATED. THE DILATOR WAS NOT REINSERTED INTO THE SHEATH PRIOR TO REMOVAL. PHOTOS PROVIDED BY THE CUSTOMER SHOW UNRAVELING AND SEPARATION OF THE SHEATH MATERIAL. THE SHEATH WAS REMOVED FROM THE PATIENT AND WAS REPLACED WITH ANOTHER MANUFACTURER'S 6-FRENCH SHEATH. 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 16848806 ↗
• MalfunctionDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AT THE END OF A PERIPHERAL PROCEDURE, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING SHEATH UPON REMOVAL OF THE SHEATH FROM THE PATIENT. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY TO TARGET THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ANATOMY WAS CALCIFIED, AND RESISTANCE WAS REPORTED UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE DILATOR WAS NOT IN PLACE UPON SHEATH REMOVAL; HOWEVER, ANOTHER MANUFACTURER'S WIRE WAS IN THE SHEATH AT THE TIME OF THE EVENT. THE SHEATH WAS MANUALLY REMOVED FROM THE PATIENT. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY WITH THE COMPLAINT DEVICE. 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 15997715 ↗
• MalfunctionMay 16, 2022Material Separation; Material Separation

  AS REPORTED, AT THE END OF A LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING SHEATH UPON REMOVAL OF THE DEVICE. ACCESS WAS OBTAINED IN THE SCARRED LEFT GROIN TO TARGET BELOW THE KNEE. THE ILIAC ARTERIES WERE NOTED TO BE MILDLY CALCIFIED, AND RESISTANCE WAS NOTED UPON ADVANCEMENT. RESISTANCE WAS ALSO ENCOUNTERED AT THE END OF THE PROCEDURE, REPORTEDLY DUE TO SCARRING. THE USER PULLED THE DEVICE FROM THE HUB, AGAIN MEETING RESISTANCE. THE HUB/VALVE THEN SEPARATED, PRIOR TO REINSERTION OF THE DILATOR. THE USER THEN REINSERTED THE DILATOR AND THE SHEATH WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THAT POINT. 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 14406583 ↗
• InjuryDec 17, 2021Break; Unraveled Material; Detachment of Device or Device Component; Break; Unraveled Material; Detachment of Device or Device Component

  UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 17JAN2022, THE SHAFT WAS UNRAVELED AND SEPARATED. THE HUB DID NOT SEPARATE AS ORIGINALLY REPORTED BY THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 13029000 ↗
• MalfunctionNov 16, 2021Leak/Splash; Leak/Splash

  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 12822155 ↗
• MalfunctionOct 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12646938 ↗
• InjurySep 28, 2021Material Separation; Material Separation

  AS REPORTED, DURING A PERIPHERAL ARTERIOGRAM WITH INTERVENTION A FLEXOR RAABE GUIDING SHEATH BROKE WITHIN THE PATIENT DURING REMOVAL. THE SHEATH HAD BEEN ADVANCED UP AND OVER THE GROIN ACCESS SITE. AS THE DEVICE WAS BEING REMOVED A 0.035 WIRE AND INTRODUCER WERE WITHIN THE SHEATH. WHEN THE DEVICE WAS BEING REMOVED IT BROKE AND A PORTION WAS RETAINED WITHIN THE PATIENT. IT IS UNKNOWN HOW OR IF THERE ARE PLANS TO REMOVE THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12540431 ↗
• InjuryFeb 15, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11327953 ↗
• MalfunctionFeb 8, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED, WHILE A FLEXOR RAABE GUIDING SHEATH WAS BEING REMOVED FROM A PATIENT, THE DISTAL END OF THE SHEATH BROKE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11292942 ↗
• MalfunctionNov 4, 2020Break

  DURING PERIPHERAL CASE OF A LOWER EXTREMITY ANGIOPLASTY, A COOK INCORPORATED FLEXOR (MODEL #: G11638) INTRODUCED RAABE MODIFICATION SHEATH BROKE IN HALF AND INNER WIRE UNRAVELED. SHEATH AND BRAIDING REMOVED SUCCESSFULLY. DEVICE GIVEN TO COOK MEDICAL SALES REPRESENTATIVE AT THE TIME. WIRES WERE WITHDRAWN INTO THE 55 RAABE CATHETER, WHICH WAS THEN PULLED BACK OVER THE AORTIC BIFURCATION. WHEN WE WERE DOING THIS, THE RAABE SHEATH BROKE INTO 2 PIECES. THE PROXIMAL PIECE WAS THEN PULLED OUT OF THE LEFT GROIN AND FLUOROSCOPIC IMAGES CONFIRMED THAT THE REMAINDER OF THE RAABE CATHETER WAS STILL STUCK OVER THE BIFURCATION OF THE AORTA. ADDITIONAL MANIPULATION REQUIRED TO REMOVE REST OF WIRE AND FOREIGN BODIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 10784514 ↗
• InjuryOct 21, 2020Unraveled Material; Unraveled Material

  AS REPORTED, AT THE COMPLETION OF AN INTERVENTIONAL PROCEDURE INVOLVING ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY, A FLEXOR RAABE GUIDING SHEATH BEGAN TO SEPARATE AT THE ILIAC BIFURCATION UPON REMOVAL OF THE DEVICE. THE USER REPORTED THAT THE DEVICE SHEARED UPON REMOVAL OVER THE BIFURCATION. A WIRE GUIDE WAS IN THE LUMEN OF THE SHEATH AT THE TIME OF SEPARATION. THE CUSTOMER PULLED AS MUCH OF THE SHEATH OUT AS POSSIBLE AND CUT THE PORTION THAT WAS OUTSIDE THE BODY, INCLUDING THE HUB. A SNARE WAS USED, ALONG WITH THE DILATOR PROVIDED WITH THE COMPLAINT DEVICE, TO REMOVE THE REMAINING PORTION OF THE SHEATH FROM THE PATIENT OVER THE WIRE GUIDE. 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

  MAUDE report 10710440 ↗
• MalfunctionSep 2, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10483320 ↗
• InjuryApr 9, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9943983 ↗
• InjuryApr 2, 2020Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOPLASTY AND STENTING PROCEDURE, A FLEXOR RAABE GUIDING SHEATH SEPARATED AT THE HUB AND UNRAVELED. THE PATIENT HAD A HISTORY OF MULTIPLE PROCEDURES INVOLVING GROIN ACCESS; THEREFORE, THE GROIN WAS SCARRED. UPON COMPLETION OF THE PROCEDURE, THE USER ATTEMPTED TO REMOVE THE SHEATH, AT WHICH TIME THE HUB SEPARATED FROM THE SHEATH AND THE SHEATH BEGAN TO UNRAVEL. THE PHYSICIAN PERFORMED A SMALL CUT-DOWN PROCEDURE TO REMOVE THE SHEATH. IMAGING WAS PERFORMED, CONFIRMING THAT ALL PORTIONS OF THE HEATH WERE SUCCESSFULLY REMOVED. THE PATIENT IS REPORTEDLY DOING WELL. THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 9915833 ↗
• MalfunctionDec 11, 2019Material Separation; Material Separation

  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 9451123 ↗