Flexor G11633Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00827002116337), received between Dec 10, 2014 and Jun 2, 2026 — classified as 2 deaths, 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Fluid/Blood Leak

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH LEAKED AS THE DEVICE WAS FLUSHED WITH SALINE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A LEAK FROM THE STOPCOCK. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE THE STOPCOCK WAS RECEIVED SEPARATED FROM THE EXTENSION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359918 ↗
• MalfunctionAug 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE DEVICE. REPORTEDLY, THE HUB SEPARATED AS THE SHEATH WAS FLUSHED WITH SALINE. ANOTHER DEVICE 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 22876573 ↗
• MalfunctionAug 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PERCUTANEOUS CORONARY ANGIOPLASTY PROCEDURE, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE DEVICE AS THE PHYSICIAN PULLED THE SHEATH BACK. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE ANATOMY WAS TORTUOUS. ANOTHER MANUFACTURER¿S 0.035-INCH, 260-CENTIMETER WIRE WAS USED DURING THE PROCEDURE, AND ANOTHER MANUFACTURER¿S 6-FRENCH GUIDING CATHETER WAS USED THROUGH THE SHEATH. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE DILATOR WAS REINSERTED PRIOR TO SHEATH REMOVAL, AND THE HUB WAS NOT USED TO PULL THE DEVICE FROM THE PATIENT. THE HUB AND PROXIMAL SHAFT WERE OUTSIDE OF THE BODY AT THE TIME OF HUB SEPARATION. 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 22714052 ↗
• MalfunctionJul 16, 2025Break; Break

  AS REPORTED, PRIOR TO USE DURING AN ANGIOGRAM, A FLEXOR RAABE GUIDING SHEATH SEPARATED MID-SHAFT AS THE PHYSICIAN ATTEMPTED TO MANUALLY CURVE THE DEVICE PRIOR TO INSERTING IT INTO THE PATIENT. THE PATIENT WAS NOT HOSPITALIZED AND 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 22519361 ↗
• MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS ORIGINALLY REPORTED, DURING A PERCUTANEOUS CORONARY INTERVENTION OF A CALCIFIED, CHRONIC TOTAL OCCLUSION, THE HEMOSTATIC VALVE CAME OUT OF A FLEXOR RAABE GUIDING SHEATH WHEN THE DILATOR WAS REMOVED FROM THE SHEATH. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER NOTED THAT THE EVENT OCCURRED WHEN REMOVING ¿THE GUIDE CATH.¿ ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ACCESS SITE WAS NOT SCARRED. ANOTHER MANUFACTURER¿S WIRE GUIDE AND ANOTHER MANUFACTURER¿S GUIDE CATHETER WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH. THE SHEATH WAS EXCHANGED FOR ANOTHER MANUFACTURER¿S 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376107 ↗
• MalfunctionDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING SHEATH DURING AN UNKNOWN PROCEDURE. ANOTHER DEVICE 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301986 ↗
• MalfunctionNov 10, 2023Contamination; Contamination

  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 18111307 ↗
• MalfunctionSep 6, 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 17693034 ↗
• DeathOct 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Cardiac Arrest

  MAUDE report 12563586 ↗
• DeathOct 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Cardiac Arrest

  MAUDE report 12563435 ↗
• MalfunctionJul 30, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252361 ↗
• MalfunctionJan 21, 2021Material Separation; Detachment of Device or Device Component; Material Separation; 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 11209189 ↗
• MalfunctionNov 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING AN ANGIOGRAM, ATHERECTOMY, AND ANGIOPLASTY, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING SHEATH UPON REMOVAL OF ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE FROM THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER TO SUCCESSFULLY COMPLETE THE PROCEDURE. UNKNOWN WIRE GUIDES, CATHETERS, AND ANGIOPLASTY BALLOONS WERE USED DURING THE PROCEDURE, AS WELL AS A COOK MICROPUNCTURE 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 Consequences Or Impact To Patient

  MAUDE report 10825463 ↗
• InjurySep 4, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 10493430 ↗
• MalfunctionSep 25, 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 9117857 ↗
• InjurySep 12, 2019Material Separation; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH SHEARED OFF INSIDE THE PATIENT. REPORTEDLY, ANOTHER SHEATH OF THE SAME TYPE DEVELOPED TIP DAMAGE UPON ATTEMPTED INSERTION INTO THE LEFT FEMORAL ARTERY (A NON-REPORTABLE EVENT). THE PATIENT'S ANATOMY WAS REPORTEDLY SCARRED. THAT DEVICE WAS REMOVED AND THE COMPLAINT DEVICE WAS INSERTED. DURING INSERTION, THE DEVICE REPORTEDLY SHEARED. AN UNKNOWN 0.035 INCH WIRE GUIDE WAS USED DURING THE PROCEDURE. REPORTEDLY, CONTRALATERAL ACCESS WAS OBTAINED AND THE LEFT ILIAC ARTERY WAS OCCLUDED WITH AN UNKNOWN BALLOON TO DECREASE BLEEDING. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. 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 Code Available

  MAUDE report 9009928 ↗
• MalfunctionJan 10, 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 8236786 ↗
• MalfunctionNov 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE VALVE OF THE FLEXOR RAABE GUIDING SHEATH DETACHED FROM THE SHEATH DURING INTRODUCTION OF THE DILATOR. THIS OCCURRED DURING A PROCEDURE TO ANGIOPLASTY AN UNSPECIFIED VESSEL IN A (B)(6) MALE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO PATIENT ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. ACCORDING TO THE COMPLAINANT, THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096043 ↗
• MalfunctionOct 25, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING INSPECTION OF A FLEXOR RAABE GUIDING SHEATH, IT WAS OBSERVED THAT THERE WAS A PIECE OF AN UNIDENTIFIED PARTICLE INSIDE THE PRIMARY PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6978404 ↗
• MalfunctionOct 24, 2017Break; Break

  A FLEXOR RAABE GUIDING SHEATH WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT IT WAS VERY DIFFICULT TO REMOVE THE DILATOR OUT OF THE FLEXOR SHEATH, AND WHILE PULLING WITH MORE FORCE THAN USUAL THE WHITE HUB OF THE DILATOR BROKE OFF. BOTH PIECES WILL BE RETURNED. 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 6974033 ↗
• InjuryJun 1, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ATHERECTOMY AND STENTING OF A SUPERFICIAL FEMORAL ARTERY (SFA) USING A FLEXOR RAABE GUIDING SHEATH, THE CHECK VALVE SEPARATED FROM THE INTRODUCER BODY. A BALLOON WAS PLACED DISTAL TO THE INTRODUCER TO AID IN REMOVING THE INTRODUCER. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SHEATH. THERE WAS NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

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

  MAUDE report 6606188 ↗
• MalfunctionApr 28, 2017Material Separation; Material Separation

  AFTER THE 7FR FLEXOR RAABE GUIDING SHEATH AND DILATOR WERE ACCESSED INTO THE PUNCTURE SITE, THE USER WAS REMOVING THE DILATOR FROM THE PATIENT BODY AND THE SHEATH CONNECTING JOINT SEPARATED FROM THE CHECK-FLO VALVE. THEREFORE, THE DILATOR IS STILL INSERTED INTO THE CHECK-FLO VALVE WITHOUT THE SHEATH COVER. 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 6530950 ↗
• MalfunctionApr 11, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT THE DEVICE WAS UNWRAPPED AND WAS ABOUT TO BE PLACED ON THE 035 WIRE WHEN CHECK-FLO VALVE PARTED FROM THE SHEATH TUBING. THE CASE WAS REPORTED TO HAVE BEEN ABANDONED AFTERWARDS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE AS THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT. ADDITIONAL INFORMATION PROVIDED ON 05APR2017, NO OTHER PROCEDURES WERE PERFORMED AS A CONSEQUENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6479939 ↗
• MalfunctionMar 17, 2017Crack; Crack

  THE NURSE OPENED THE FLEXOR RAABE GUIDING SHEATH FOR USE DURING VASCULAR SURGERY AND DISCOVERED THAT IT WAS UNABLE TO BE USED DUE TO A CRACKED VALVE. THEREFORE, THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6413083 ↗
• MalfunctionMar 3, 2017Material Separation; Material Separation

  AS REPORTED TO CUSTOMER RELATIONS: DURING AN ILIAC/SFA PROCEDURE, THE HUB OF THE FLEXOR RAABE GUIDING SHEATH CAME APART AS THE SHEATH WAS OVER THE WIRE. ANOTHER MANUFACTURER'S SHEATH WAS USED TO COMPLETE THE PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017, WHILE RETRACTING THE FLEXOR RAABE GUIDING SHEATH, THE HUB CAME APART FROM SHEATH ITSELF. IT WAS STATED THE PATIENT'S ILIAC WAS TORTUOUS. THE SHEATH AND STENT WERE BOTH REMOVED MANUALLY OVER THE WIRE. ANOTHER MANUFACTURER'S SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO FRAGMENTS REMAINED INSIDE THE PATIENT, THE PATIENT WAS UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6377869 ↗