Flexor G11635Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00827002116351), received between Aug 15, 2016 and Dec 30, 2025 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Break; Difficult to Remove; Break; Difficult to Remove

  AS REPORTED, DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) VIA A LEFT RADIAL ARTERY APPROACH, A FLEXOR RAABE GUIDING SHEATH BECAME STUCK IN THE PATIENT. PER THE REPORTER, ADVANCEMENT OF THE SHEATH INTO THE RADIAL ARTERY WAS ¿SLOW¿, AND RESISTANCE WAS ENCOUNTERED. UPON ENCOUNTERING RESISTANCE, THE PHYSICIAN STOPPED ADVANCING THE SHEATH AND ATTEMPTED TO WITHDRAW THE DEVICE; HOWEVER, THE SHEATH WAS STUCK IN THE VESSEL AND COULD NOT BE REMOVED. SUBSEQUENT ATTEMPTS TO REMOVE THE SHEATH, USING LARGER WIRE GUIDES AND BALLOON DILATION/¿PUSHES¿, WERE UNSUCCESSFUL. THE USER THEN DECIDED TO SURGICALLY REMOVE THE SECTION OF THE VESSEL IN WHICH THE SHEATH WAS STUCK. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A SEPARATED AND UNRAVELED SECTION OF THE SHEATH. PER THE REPORTER, THE PATIENT WAS NOT HOSPITALIZED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: Insufficient Information

  MAUDE report 23927004 ↗
• MalfunctionDec 12, 2025Detachment 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 23791945 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN AORTIC ARCH REPAIR PROCEDURE, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE DEVICE. THE DEVICE WAS USED COAXIAL WITHIN AN UNSPECIFIED 10-FRENCH SHEATH, OVER AN UNKNOWN 0.035-INCH WIRE GUIDE. DURING THE ¿CROSS OVER, COAXIAL MANEUVER¿, THE HUB 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 22675887 ↗
• MalfunctionAug 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ATHERECTOMY OF THE LEFT LEG, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING 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 19961907 ↗
• MalfunctionAug 12, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ATHERECTOMY OF THE RIGHT LEG, A FLEXOR RAABE GUIDING SHEATH UNRAVELED AND SEPARATED UPON REMOVAL OF THE DEVICE. PER THE REPORTER, WHILE REMOVING THE SHEATH, IT "SPLIT" AND BEGAN TO "SHRED". REPORTEDLY, THE "LEFT GILL CANAL" WAS REMOVED AND A SNARE LOOP WAS USED TO REMOVE THE SEPARATED PORTION OF THE SHEATH FROM THE PATIENT, THROUGH ENTRY INTO THE "LEFT GILL". THE PATIENT, WHO WAS HOSPITALIZED, REPORTEDLY DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, IT WAS DAMAGED, UNRAVELED, AND SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960765 ↗
• MalfunctionAug 12, 2024Detachment 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 19960692 ↗
• MalfunctionDec 19, 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 18358416 ↗
• MalfunctionFeb 6, 2023Break; Break

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, A FLEXOR RAABE GUIDING SHEATH WAS OPENED AND THE STOPCOCK WAS SEPARATED FROM THE CLEAR SIDE-ARM TUBING. THE SHEATH WAS NOT USED, AND ANOTHER PRODUCT WAS USED TO CONTINUE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305168 ↗
• MalfunctionOct 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, IN THE MIDDLE OF A PROCEDURE INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITHIN THE LEFT UPPER SUPERFICIAL FEMORAL ARTERY (SFA), THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED. THE ACCESS SITE WAS REPORTEDLY SCARRED FROM PREVIOUS PROCEDURES, AND ACCESS INTO THE GROIN WAS DIFFICULT; HOWEVER, THE ANATOMY WAS NOT CALCIFIED AND THE USER DENIED MEETING RESISTANCE. AS THE USER MOVED THE SHEATH PROXIMALLY TO COMPLETE PTA OF THE UPPER SFA, THE HUB SEPARATED. ANOTHER MANUFACTURER'S WIRE AND BALLOON WERE IN THE SHEATH LUMEN AT THE TIME OF THE EVENT. THE HUB WAS NOT USED TO PULL THE DEVICE. THE DILATOR WAS NOT IN PLACE AT THE TIME OF THE EVENT. THE SHEATH WAS CLAMPED AND EXCHANGED FOR A NEW SHEATH, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15553491 ↗
• MalfunctionJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A FLEXOR RAABE GUIDING SHEATH "BROKE" WHEN IT WAS PULLED. THE PROVIDED PHOTO SHOWS THE HUB SEPARATED FROM THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851295 ↗
• MalfunctionApr 27, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF A STENT WITHIN A STENOSED CAROTID ARTERY, A FLEXOR RAABE GUIDING SHEATH LEAKED FROM THE VALVE. AFTER THE SHEATH WAS PLACED, BLOOD WAS NOTED TO LEAK FROM THE VALVE; THEREFORE, THE SHEATH WAS REMOVED AND REPLACED. 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 14219943 ↗
• MalfunctionJan 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, A FLEXOR RAABE GUIDING SHEATH LEAKED. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. 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 13146104 ↗
• MalfunctionFeb 10, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 25MAR2021. AS THE USER PULLED THE DILATOR OUT OF THE SHEATH, THE SHEATH UNRAVELED. A NEW DEVICE WAS OPENED AND WAS USED SUCCESSFULLY.

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

  MAUDE report 11308354 ↗
• InjuryFeb 17, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING A PATIENT WITH A HISTORY OF VASCULOPATHY AND MULTIPLE SURGICAL INTERVENTIONS, A FLEXOR RAABE GUIDING SHEATH SEPARATED IN THE PATIENT UPON REMOVAL OF THE DEVICE. THE PATIENT RECEIVED CONSCIOUS SEDATION, USING VERSED AND DEMEROL, FOR THE PROCEDURE. SCAR TISSUE WAS REPORTED AT THE LEFT COMMON FEMORAL ARTERY ACCESS SITE AND RESISTANCE WAS REPORTED UPON DEVICE REMOVAL. THE SHEATH WAS REPORTEDLY IN PLACE FOR POSSIBLY FORTY-FIVE MINUTES. AN UNKNOWN WIRE GUIDE WAS IN THE LUMEN OF THE DEVICE AT THE TIME OF DISTAL SHAFT SEPARATION; THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL. FOLLOWING THE DEVICE SEPARATION, THE PATIENT WAS TRANSPORTED TO A HOSPITAL WHERE AN OPEN SURGICAL REMOVAL OF THE DISTAL PORTION OF THE DEVICE WAS PERFORMED. THE PATIENT WAS DISCHARGED TWO DAYS LATER.

  Patient problems: No Code Available

  MAUDE report 9716632 ↗
• MalfunctionJan 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, UPON INSPECTION WITHIN A DISTRIBUTION FACILITY, AN UNIDENTIFIED PARTICLE WAS FOUND INSIDE THE FLEXOR RAABE GUIDING SHEATH PACKAGING. THE DEVICE DID NOT MAKE CONTACT WITH ANY PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9590320 ↗
• MalfunctionJan 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING COILING OF A CEREBRAL ANEURYSM INVOLVING A PATIENT WITH AN ACUTE SUBARACHNOID HEMORRHAGE, THE VALVE OF A FLEXOR RAABE GUIDING SHEATH LEAKED. ANOTHER MANUFACTURER'S GUIDEWIRE AND AN UNKNOWN 8 FRENCH SHORT-SHEATH WERE USED DURING THE PROCEDURE. AFTER INSERTION OF THE COMPLAINT DEVICE, THE CHECK-FLO VALVE LEAKED BLOOD CONTINUOUSLY. 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 9547172 ↗
• MalfunctionOct 30, 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 Patient Involvement

  MAUDE report 9254794 ↗
• MalfunctionOct 23, 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 9226782 ↗
• MalfunctionSep 30, 2019Detachment 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 Consequences Or Impact To Patient

  MAUDE report 9135335 ↗
• MalfunctionJun 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PULMONARY ARTERY BALLOON DILATION PROCEDURE INVOLVING A (B)(6) YEAR-OLD MALE PATIENT WEIGHING (B)(6) KILOGRAMS WITH A HISTORY OF PULMONARY ARTERIAL HYPERTENSION, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE DEVICE. THE SEPARATION REPORTEDLY OCCURRED AFTER THE SHEATH WAS PARTIALLY INSERTED INTO THE PATIENT. THE PATIENT'S ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR CALCIFIED. ANOTHER (UNKNOWN) DEVICE WAS USED TO COMPLETE THE PROCEDURE 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 8716534 ↗
• MalfunctionMar 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO OPENING THE FLEXOR RAABE GUIDING SHEATH, A HAIR WAS OBSERVED INSIDE OF THE PACKAGING. THE DEVICE DID NOT COME INTO CONTACT WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7331046 ↗
• MalfunctionAug 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FLEXOR RAABE GUIDING SHEATH WAS NOTED TO HAVE HAIR IN THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764511 ↗
• MalfunctionAug 15, 2016Material Separation; Material Separation

  TOWARDS THE END OF THE ANGIOGRAM (ANGIOPLASTY ON LEG) PROCEDURE (AT THE STAGES OF CLOSING), THE CHECK-FLO VALVE COMPLETELY SEPARATED FROM THE FLEXOR RAABE GUIDING SHEATH DURING REMOVAL. ANOTHER MANUFACTURERS 7X11 SHORT SHEATH WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 5875641 ↗