Flexor G11637Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002116375), received between Oct 27, 2016 and Nov 25, 2025 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING SHEATH DURING MANIPULATION AND INSERTION OF THE DILATOR INTO THE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643568 ↗
• MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF STENTS IN THE PULMONARY VEIN, A FLEXOR RAABE GUIDING SHEATH'S HUB SEPARATED. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL VEIN TO TARGET BOTH THE LEFT AND RIGHT PULMONARY VEINS. THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED, HOWEVER, IT IS UNKNOWN IF IT WAS SCARRED. MULTIPLE UNSPECIFIED STENTS AND BALLOONS WERE ADVANCED/REMOVED THROUGH THE SHEATH PRIOR TO THE HUB SEPARATION. UPON REMOVAL OF THE COMPLAINT DEVICE FOR A SHEATH EXCHANGE, RESISTANCE WAS FELT, AND THE "BACK HUB DISCONNECTED FROM THE INTRODUCER SHEATH SHAFT". THE DILATOR WAS NOT IN PLACE WHEN THE SEPARATION OCCURRED, AND THE SHEATH HUB WAS USED TO PULL THE DEVICE. THE USER CONTINUED REMOVING THE SHEATH OVER AN UNSPECIFIED WIRE AFTER THE SEPARATION, FEEDING THE WIRE THROUGH THE HUB AND SHEATH IN ONE HAND WHILE HOLDING THE HUB AND SHEATH TOGETHER IN THE OTHER HAND. PER THE REPORTER, THIS DID NOT CAUSE ANY PROBLEMS AS THE USER HAD AN UNSPECIFIED EIGHT FRENCH SHEATH READY TO GO. 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 E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567423 ↗
• MalfunctionJan 8, 2024Material Split, Cut or Torn; 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 18466092 ↗
• InjuryJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AT THE END OF A NEUROLOGICAL PROCEDURE INVOLVING A THROMBECTOMY TO TREAT A STROKE, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING SHEATH. THE PATIENT HAD BEEN PREVIOUSLY HOSPITALIZED DUE TO THE STROKE. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET THE CAROTID ARTERY/BRAIN. THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED UPON INSERTION OR REMOVAL OF THE DEVICE. UPON REMOVAL OF AN UNSPECIFIED THROMBECTOMY CATHETER THROUGH THE SHEATH, THE HUB OF THE SHEATH SEPARATED. THE PATIENT WAS SENT TO SURGERY FOR SURGICAL REMOVAL OF THE SEPARATED DEVICE FRAGMENT. THE PATIENT IS REPORTEDLY DOING WELL. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427545 ↗
• MalfunctionSep 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A THROMBECTOMY OF THE FEMORAL ARTERY, A FLEXOR RAABE GUIDING SHEATH SEPARATED AT THE HUB. THE USER REPORTED RESISTANCE WHILE CHANGING THE DILATOR, AND THE HUB THEN SEPARATED FROM THE SHEATH. 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 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 10493383 ↗
• MalfunctionJul 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED ON 10AUG2020: THE USER GAINED ACCESS THROUGH THE FEMORAL ARTERY AND ADVANCED THE SHEATH TO THE PULMONARY ARTERY. THE DILATOR WAS THEN REMOVED, BUT WHILE THE USER WAS HOLDING THE HEMOSTATIC VALVE THEY FOUND THE BLACK SHEATH AND VALVE SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240234 ↗
• InjuryJun 8, 2020Material Separation; Unraveled Material; Detachment of Device or Device Component; Material Separation; 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: Foreign Body In Patient

  MAUDE report 10127874 ↗
• MalfunctionJun 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING IMPLANTATION OF AN UNKNOWN STENT, A FLEXOR RAABE GUIDING SHEATH LEAKED AT THE HUB AFTER THE SHEATH WAS INSERTED INTO THE PATIENT. ANOTHER MANUFACTURER'S WIRE GUIDE AND UNKNOWN 5-FRENCH CATHETER WERE USED THROUGH THE VALVE. CONTRAST WAS INJECTED INTO THE HUB AND THE CONTRAST WAS "PUSHED OUT BY THE REACTION FORCE". THE COMPLAINT DEVICE WAS REMOVED AND 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 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 10108728 ↗
• MalfunctionJan 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM OF THE ILIAC VEIN VIA JUGULAR ACCESS, A FLEXOR RAABE GUIDING SHEATH SEPARATED AT THE HUB. THE (B)(6) YEAR-OLD PATIENT HAD A HISTORY OF A PORTOSYSTEMIC SHUNT AND AN ATRIAL SEPTAL DEFECT. AN UNKNOWN INTRODUCER AND WIRE GUIDE WERE USED DURING THE PROCEDURE. REPORTEDLY, THE SHEATH WAS COMPLETELY REMOVED AND REPLACED WITH ANOTHER 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 Consequences Or Impact To Patient

  MAUDE report 9539380 ↗
• MalfunctionNov 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, PRIOR TO PATIENT CONTACT, THE HUB OF THE FLEXOR RAABE GUIDING SHEATH SEPARATED. UPON INSERTING THE DILATOR INTO THE SHEATH, THE SHEATH DETACHED FROM THE HUB. REPORTEDLY, THE PROCEDURE WAS COMPLETED AFTER CHANGING TO A NEW DEVICE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9306008 ↗
• MalfunctionFeb 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, A PATIENT OF UNKNOWN AGE AND GENDER UNDERWENT AN IDE-CUSTOM MADE DEVICE PROCEDURE IN WHICH THE FLEXOR RAABE GUIDING SHEATH WAS USED. THE SHEATH HAD BEEN USED SEVERAL TIMES DURING THIS PROCEDURE AND, REPORTEDLY, UNDERWENT A LOT OF MANIPULATION DUE TO TORTUOUS ANATOMY. THE SHEATH WAS TAKEN IN THE ANCILLARY ARTERY DOWN TO THE CELIAC ARTERY. DURING ONE OF THE RE-INTRODUCTIONS OF THE GUIDING SHEATH THE VALVE SEPARATED FROM THE SHEATH. REPORTEDLY, THE SHEATH HAD BEEN IN PLACE APPROXIMATELY TWENTY MINUTES. NOTHING DETACHED IN THE PATIENT AND THE PHYSICIAN HAD TO CONTINUE TO USE THIS SHEATH UNTIL ANOTHER MANUFACTURER'S STENT WAS DEPLOYED. ONCE THE STENT WAS DEPLOYED THE SHEATH WAS THEN EXCHANGED. IT WAS CONFIRMED THE PATIENT EXPERIENCED BLOOD LOSS WHICH WAS DESCRIBED AS "UNDER ONE PINT". THE PROCEDURE WAS COMPLETED AND THE PATIENT'S OUTCOME WAS "GOOD." IT WAS REPORTED THE PATIENT DID NOT RETAIN ANY PORTION OF THE COMPLAINT DEVICE, REQUIRE ADDITIONAL PROCEDURES, OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8348429 ↗
• MalfunctionOct 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, AN (B)(6) YEAR-OLD MALE WAS UNDERGOING A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN WAS ADVANCING THE FLEXOR RAABE GUIDING SHEATH FROM THE LEFT AXILLARY TO THE SUPERIOR MESENTERIC ARTERY OVER A ROSEN WIRE. AFTER THE FLEXOR RAABE GUIDING SHEATH WAS IN POSITION, THE PHYSICIAN REMOVED THE DILATOR AND THE HUB OF THE SHEATH DETACHED COMPLETELY AND STARTED LEAKING BLOOD. APPROXIMATELY 100 CC OF BLOOD WAS LOST BEFORE THE COMPLAINT SHEATH WAS REMOVED. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT ADVERSE EFFECT WAS REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY NOR WERE ANY ADDITIONAL PROCEDURES REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7956935 ↗
• MalfunctionJul 20, 2018Material Separation; Material Separation

  IT WAS REPORTED, THE FLEXOR RAABE GUIDING SHEATH HUB'S SEPARATED DURING A FENESTRATED ENDOVASCULAR AORTIC REPAIR PROCEDURE. THE 8 FRENCH FLEXOR RAABE GUIDING SHEATH WAS TRACKING FROM THE ACCESS SITE AT THE LEFT AXILLARY TO THE SUPERIOR MESENTERIC ARTERY OVER THE GUIDE WIRE WITHOUT ISSUE. ONCE THE SHEATH WAS IN POSITION, THE DILATOR WAS REMOVED AND THE HUB OF THE DEVICE CAME OFF CAUSING BLEEDING TO OCCUR. THE DEVICE WAS REMOVED COMPLETELY AND ANOTHER DEVICE WAS USED. 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 7707569 ↗
• MalfunctionMay 17, 2018Material 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 Known Impact Or Consequence To Patient

  MAUDE report 7523145 ↗
• MalfunctionMar 24, 2017Material Separation; Material Separation

  DURING AN UNKNOWN PROCEDURE ON THE (B)(6) YEAR OLD MALE PATIENT, RESISTANCE WAS EXPERIENCED WITH THE INTRODUCER. DURING ADVANCEMENT OF THE INTRODUCER, THE VALVE RELEASED (SEPARATED) FROM THE INTRODUCER (SEPARATED FROM HUB). NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6432276 ↗
• InjuryOct 27, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A THORCO-ABDOMINAL ANEURYSM REPAIR PROCEDURE. DURING THE MANIPULATION OF THE SHEATH THE INSIDE OF THE VALVE/CLEAR INNER DISC CAME OUT OF THE VALVE ASSEMBLY. THE PHYSICIAN SWABBED OUT THE SHEATH PLANNING TO SWITCH OUT THE SHEATH. THE PATIENT REQUIRED A TRANSFUSION OF 1 UNIT OF BLOOD.

  Patient problems: No Code Available

  MAUDE report 6060651 ↗