Flexor G12836Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002128361), received between Mar 9, 2016 and Jun 8, 2026 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A THROMBECTOMY FOR TREATMENT OF A DEEP VEIN THROMBOSIS IN THE LEFT LEG, THE HUB OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED FROM THE DEVICE AS THE USER ATTEMPTED TO UNLOCK IT FROM A FEMALE LUER LOCK CONNECTING TUBE. ACCESS WAS OBTAINED IN THE POPLITEAL VEIN, AND THE ACCESS SITE WAS NORMAL. THE ANATOMY WAS NOT STENOSED, CALCIFIED, OR TORTUOUS, AND RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR ADVANCEMENT OF THE SHEATH. NO OTHER DEVICES WERE USED THROUGH THE SHEATH. THE SHEATH WAS REMOVED, AND A NEW SHUTTLE 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 OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427599 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  AS REPORTED, THE HUBS OF TWO FLEXOR SHUTTLE TIBIAL GUIDING SHEATHS SEPARATED DURING A PROCEDURE INVOLVING AN AORTIC DISSECTION WITH FALSE LUMEN. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE ACCESS SITE AND ANATOMY WERE REPORTEDLY ¿NORMAL¿, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF THE SHEATH. A COOK COIL WAS USED THROUGH THE SHEATH, AS WELL AS ANOTHER MANUFACTURER¿S WIRE GUIDE AND ANOTHER MANUFACTURER¿S VASCULAR PLUG. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF ANY DEVICE THROUGH THE SHEATH. PER THE REPORTER, WHEN THE VASCULAR PLUG WAS ALMOST IN PLACE, THE PHYSICIAN WANTED TO ADJUST THE LOCATION, SO THE PLUG WAS PULLED BACK, AT WHICH POINT THE USER NOTED THAT THE SHEATH HAD SEPARATED FROM THE HUB. RESISTANCE WAS ENCOUNTERED DURING SHEATH REMOVAL, AND THE HUB WAS USED TO PULL THE SHEATH FROM THE PATIENT. THE SHEATH WAS REMOVED AND EXCHANGED FOR ¿ANOTHER ONE¿, AND THE USER REPORTEDLY TESTED THE ¿NEW ONE¿ WITH ¿NORMAL STRENGTH¿; HOWEVER, THE HUB OF THAT DEVICE ALSO SEPARATED. THE SHEATH WAS EXCHANGED FOR A THIRD DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119498 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED AT THE VALVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 23741593 ↗
• MalfunctionMay 23, 2023Detachment 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 16986808 ↗
• MalfunctionMay 23, 2023Detachment 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 16986716 ↗
• MalfunctionJul 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING BILATERAL "IBD" IN AN EXISTING COOK ZENITH GRAFT DEVICE FOR DISEASE PROGRESSION, VIA FEMORAL AND AXILLARY ACCESS, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED AT THE HUB. THE SHEATH WAS ADVANCED OVER ANOTHER MANUFACTURER'S WIRE VIA THE LEFT AXILLARY ARTERY. THE USER REPORTED THAT TRACKABILITY OF THE DEVICE WAS CHALLENGING. THE ANATOMY WAS NOT SIGNIFICANTLY TORTUOUS OR SCARRED. AS THE USER ATTEMPTED TO ADVANCE THE SHEATH OVER THE WIRE TO CANNULATE THE INTERNAL ARTERY, THE HUB SEPARATED FROM THE SHEATH. THE SHEATH WAS THEN REMOVED FROM THE PATIENT BY PULLING FROM THE HUB, WITH THE DILATOR IN PLACE. WHEN THE SHEATH WAS REMOVED HALFWAY, THE PHYSICIAN REMOVED THE DEVICE BY PULLING WITH ONE HAND ON THE HUB AND ONE HAND ON THE SHEATH. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PER THE USER, THE PRE-EXISTING COOK ZENITH GRAFT DID NOT IMPACT THE DIRECTION/INTRODUCTION OF 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040147 ↗
• MalfunctionNov 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING AN AORTIC DISSECTION WITH A FALSE LUMEN, THE HUBS OF TWO FLEXOR SHUTTLE TIBIAL GUIDING SHEATHS SEPARATED. AN UNSPECIFIED "PLUG" WAS ALMOST IN PLACE, BUT THE PHYSICIAN WANTED TO ADJUST THE LOCATION, SO HE PULLED THE "PLUG" BACK AND NOTED THAT THE HUB OF THE FIRST SHEATH HAD SEPARATED FROM THE SHAFT. THE SHEATH HAD BEEN IN PLACE FOR APPROXIMATELY FORTY MINUTES AND THE DILATOR WAS NOT IN THE SHEATH AT THE TIME OF HUB SEPARATION; HOWEVER THE UNSPECIFIED 22MM PLUG WAS IN THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER FROM THE SAME LOT. THE PHYSICIAN USED "NORMAL STRENGTH" TO TEST THE NEW SHEATH AND THE HUB SEPARATED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS CONTINUED. THE SHEATH HUBS WERE USED TO PULL THE SHEATHS FROM THE PATIENT. RESISTANCE WAS NOT REPORTED. THE ANATOMY WAS NOT TORTUOUS, SCARRED, OR CALCIFIED. ALTHOUGH THE DILATOR WAS NOT IN THE DEVICE LUMEN AT THE TIME OF HUB SEPARATION, REPORTEDLY, THE DILATOR AND SHEATH WERE WITHDRAWN AS A UNIT. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENT. THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788348 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716337 ↗
• MalfunctionJul 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LOWER LEG ANGIOPLASTY, THE HUB OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED FROM THE DEVICE. THE PRODUCT WAS REMOVED FROM THE PACKAGE AND IT WAS NOTED THAT THE HUB WAS NOT SECURE. THE HUB SEPARATED AFTER IT WAS TOUCHED. THE PACKAGE WAS NOT DAMAGED. THE DEVICE WAS STORED BY HANGING IN PULL-OUT SHELVES. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 10233175 ↗
• InjuryMay 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED VIA MEDWATCH (MW5094179), AT THE END OF A CEREBRAL ANGIOGRAM, THE HUB OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED FROM THE DEVICE UPON REMOVAL FROM THE PATIENT'S RIGHT GROIN. THE MEDWATCH REPORT INDICATES THAT THE PATIENT REQUIRED AN INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE; HOWEVER, DETAILS OF THE INTERVENTION WERE NOT PROVIDED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 10048793 ↗
• MalfunctionJul 30, 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 7732111 ↗
• MalfunctionApr 28, 2017Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE USING A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH, THE JUNCTION FRACTURED WHEN THE END USER SCREWED THE SIDE-ARM VALVE OF THE SHEATH TO THE CHECK-FLO VALVE. AT THE TIME OF THIS REPORT, PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6531211 ↗
• MalfunctionMar 1, 2017Material Separation; Material Separation

  DURING AN UNSPECIFIED PROCEDURE, THE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH BROKE AND BLOOD SQUIRTED OUT. THE AMOUNT OF BLOOD WAS NOT DEFINED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6369515 ↗
• MalfunctionMar 9, 2016Material Separation; Material Separation

  INFORMATION WAS PROVIDED THAT THE (B)(6) MALE PATIENT WITH A PREEXISTING CONDITION OF CIA (A COMMON ILIAC ARTERY ANEURYSM) HAD A FLEX GRAFT AND A RIGHT ILIAC BRANCH DEVICE (IBD) INSERTED IN 2011. THE PATIENT REQUIRED AN ADDITIONAL IBD TO LEFT CIA; THEREFORE, REQUIRED A LONG SHEATH INSERTED VIA THE AXILLARY ARTERY. WHEN THE 8FR SHUTTLE SHEATH WAS INSERTED INTO THE AXILLARY ARTERY, THE SHEATH SEPARATED OVER THE WIRE FROM THE WHITE HUB AT THE PROXIMAL END. THE SHEATH HAD TO BE REMOVED AND A SECOND 8FR SHEATH WAS OPENED AND USED FOR THE REMAINDER OF THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, 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 5488754 ↗