Flexor G13264Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00827002132641), received between Mar 14, 2016 and Sep 30, 2026 — classified as 10 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionSep 30, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50951556 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA A RETROSPECTIVE STUDY INVOLVING CHART REVIEW, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS USED DURING A DIAGNOSTIC ANGIOGRAM FOR STENOSIS OF THE LEFT CAROTID ARTERY, AFTER WHICH THE PATIENT DEVELOPED A VASCULAR THROMBOSIS/OCCLUSION, ON THE SAME DAY AS THE PROCEDURE. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY USING A MICROPUNCTURE KIT UNDER ULTRASOUND GUIDANCE, AND THE FLEXOR SHEATH WAS ADVANCED OVER AN UNSPECIFIED J-WIRE. THE ACCESS SITE WAS NOT SCARRED. THE TIP OF THE INTRODUCER WAS ADVANCED TO THE LEFT INTERNAL CAROTID ARTERY. VARIOUS WIRES, CATHETERS, BALLOONS, AND A STENT WERE ADVANCED THROUGH THE COMPLAINT DEVICE. ALL DEVICES WERE SUCCESSFULLY INTRODUCED INTO THE INTENDED TARGET (ANATOMICAL) LOCATION DURING THE PROCEDURE. ANOTHER MANUFACTURER¿S STENT WAS ADVANCED OVER ANOTHER MANUFACTURER¿S WIRE, POSITIONED ACROSS THE STENOSIS, AND WAS PLACED IN THE LEFT CAROTID ARTERY. THERE WERE NO DEFICIENCIES OF THE COOK SHEATH NOTED DURING THE PROCEDURE. THE PATIENT DEVELOPED A VASCULAR THROMBOSIS/OCCLUSION IN THE RIGHT COMMON FEMORAL ARTERY THE SAME DAY AS THE PROCEDURE. A HEPARIN DRIP WAS USED TO TREAT THE PATIENT. THE EVENT WAS CONSIDERED RESOLVED BY THIRTY D

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18130281 ↗
• InjurySep 15, 2023Break; Peeled/Delaminated; Stretched; Unraveled Material; Material Deformation; Break; Peeled/Delaminated; Stretched; Unraveled Material; Material Deformation

  AS REPORTED, DURING AN ANGIOGRAM OF THE LOWER EXTREMITY, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE. CONTRALATERAL ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY AND THE SHEATH WAS ADVANCED UP AND OVER THE BIFURCATION. THE ACCESS SITE WAS SCARRED, THE ANATOMY WAS TORTUOUS, AND THE ILIAC ARTERIES WERE VERY CALCIFIED. AN UNKNOWN "M" WIRE WAS USED WITH THE DEVICE, AND ANOTHER MANUFACTURER'S WIRE AND TWO COOK CATHETERS WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH; HOWEVER, RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH, EVEN WITH THE DILATOR IN PLACE. REPORTEDLY, THE SHEATH SHAFT HAD ALREADY SEPARATED WHEN THE DILATOR WAS REINSERTED INTO THE SHEATH. A BILATERAL GROIN CUTDOWN WAS PERFORMED TO REMOVE THE SEPARATED SHEATH FRAGMENTS FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY, AS THE USER INTENDED TO TREAT THE SUPERFICIAL FEMORAL ARTERY, BUT DID NOT "GET TO IT" AFTER SWITCHING TO AN OPEN PROCEDURE. PER THE REPORTER, THE PATIENT'S VESSELS WERE VERY CALCIFIED, AND THE PHYSICIAN BELIEVES THAT THE SHEATH WAS CUT BY CALCIUM. UPON RETURN AND

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756247 ↗
• MalfunctionMay 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AS ORIGINALLY REPORTED, UPON OPENING THE PACKAGE, THE "HEMOSTATIC VALVE OF THE Y VALVE" WAS MISSING FROM A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH. A PHOTO PROVIDED BY THE CUSTOMER SHOWS ONLY THE STOPCOCK, ATTACHED TO THE SIDE-ARM TUBING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, IT WAS DISCOVERED THAT THE SILICONE DISC/VALVE WAS MISSING FROM THE TUOHY-BORST VALVE, WHICH LEAKED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863237 ↗
• MalfunctionApr 10, 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 16709508 ↗
• MalfunctionAug 25, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, PRIOR TO PATIENT CONTACT, A WHITE WAXY SUBSTANCE WAS NOTED ON A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH. DURING DEVICE PREPARATION, THE DILATOR WAS DIFFICULT TO INSERT INTO THE SHEATH AND AFTER "BARELY COMBINING", THE WHITE WAXY SUBSTANCE WAS NOTED. THE DEVICE WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293730 ↗
• MalfunctionDec 1, 2021Break; Material Separation; Break; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE. A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE. REPORTEDLY, THE PHYSICIAN CUT THE SHEATH. THE DISTAL SECTION OF THE SHEATH WAS NOTED TO BE COMPRESSED UPON REMOVAL. THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL/SEPARATION. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913172 ↗
• InjuryApr 26, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 06MAY2021. THE DEVICE SEPARATED AT THE SHAFT AND HUB. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY TO TARGET THE RIGHT INTERNAL CAROTID ARTERY. THE COMMON FEMORAL ARTERY WAS SCARRED AND CALCIFIED, AND RESISTANCE WAS REPORTED UPON BOTH INSERTION AND REMOVAL OF THE COMPLAINT DEVICE. AN UNKNOWN DEVICE WAS IN THE LUMEN OF THE SHEATH AT THE TIME OF SEPARATION; HOWEVER, THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE DEVICE. ANOTHER MANUFACTURER'S CAROTID STENT WAS DELIVERED THROUGH THE SHEATH DURING THE PROCEDURE. AN ADDITIONAL SURGERY WAS PERFORMED TO SUCCESSFULLY REMOVE THE SEPARATED SHEATH ,AND THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11724016 ↗
• InjuryMar 17, 2021Material Split, Cut or Torn

  PATIENT WAS UNDERGOING A CAROTID STENT PLACEMENT. THE PHYSICIAN WAS REMOVING A SHUTTLE SHEATH FROM HIS LEFT FEMORAL ARTERY AND IT TORE APART LEAVING A PORTION OF THE SHEATH IN THE PATIENTS ARTERY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11514944 ↗
• InjuryFeb 8, 2021Material Separation; Material Separation

  AS REPORTED, DURING A NEUROLOGICAL INTERVENTION, THE TIP OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SHEARED/SEPARATED IN THE PATIENT. THE SEPARATED PORTION WAS RETRIEVED AND NOTHING REMAINS IN THE PATIENT. IT IS UNKNOWN AT THIS TIME HOW THE SEPARATED PORTION OF THE SHEATH WAS RETRIEVED OR HOW THE PROCEDURE WAS COMPLETED. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SEPARATED SHEATH MATERIAL WAS CONNECTED BY ELONGATED COIL. 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 Code Available

  MAUDE report 11292429 ↗
• MalfunctionDec 3, 2020Detachment 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 10938688 ↗
• InjuryOct 20, 2020Material Separation; Material Separation

  AS REPORTED, DURING A MESENTERIC ANGIOGRAM WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT, THE SHAFT OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH FRACTURED AND SEPARATED UPON REMOVAL OF THE DEVICE FROM THE RADIAL ARTERY. THE PATIENT WAS SENT TO THE OPERATING ROOM AND THE DEVICE WAS SURGICALLY REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 10706649 ↗
• InjuryOct 8, 2020Fracture; Material Separation

  FRACTURE AND SEPARATION OF THE LEFT RADIAL ARTERY SHEATH UPON SHEATH REMOVAL. PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REMOVAL. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10657692 ↗
• MalfunctionSep 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570171 ↗
• MalfunctionJul 15, 2020Fracture

  DURING CAROTID AND CORONARY ANGIOGRAPHY PROCEDURE, FLEXOR SHUTTLE SHEATH FRACTURED WHILE BEING REMOVED FROM THE RIGHT FEMORAL ARTERY INSERTION SITE. THE SHEATH BECAME NEARLY DISSOCIATED ALONG THE SHAFT. THE INTERVENTIONALIST WAS ABLE TO REMOVE THE SHEATH WITH GENTLE CONTINUOUS TRACTION AND ALL PIECES OF THE SHEATH WERE REMOVED WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10277588 ↗
• MalfunctionJul 6, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 18SEP2020. THE EVENT OCCURRED IN THE CARDIAC CATHETERIZATION LAB. PHOTOS OF THE COMPLAINT DEVICE SHOW UNRAVELING AND SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10232884 ↗
• MalfunctionNov 27, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  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 9385659 ↗
• InjuryMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA A USER FACILITY MEDWATCH REPORT THAT DURING A CAROTID STENT WITH DISTAL EMBOLIZATION PROTECTION PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, THE "COATING WAS NOTED TO BE SHEARED" FROM A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH. ADDITIONAL INFORMATION WAS RECEIVED DURING FOLLOW UP, AND IT WAS CONFIRMED THAT THE DEVICE WAS IN FACT INTRODUCED IN THE PATIENT. THE OPERATION REPORT READS AS FOLLOWS: ¿USING ROADMAP TECHNIQUE, [ANOTHER MANUFACTURER'S] 0.035 SUPPORTIVE WIRE WAS PLACED IN EXTERNAL CAROTID ARTERY. OVER THIS SUPPORTIVE WIRE, [ANOTHER MANUFACTURER'S] 5-FRENCH CATHETER AND SHEATH WERE REMOVED, AND A 6-FRENCH SHUTTLE SHEATH WAS ADVANCED AND PLACED IN THE DISTAL LEFT COMMON CAROTID ARTERY. THERE WAS UNRAVELING OF THE DISTAL END OF SHEATH DUE TO DEFECT AND WE REMOVED IT AND PLACED [ANOTHER MANUFACTURER'S] SIX FRENCH SHEATH IN DISTAL LEFT COMMON CAROTID ARTERY.¿ AFTER PLACING THE SIX FRENCH SHEATH IN THE DISTAL LEFT COMMON CAROTID ARTERY, IT WAS PROVIDED THAT THE PROCEDURE WAS COMPLETED USING A 5.5 MM FILTER (MANUFACTURER NOT SPECIFIED), A 6MM ANGIOPLASTY BALLOON (MANUFACTURER NOT SPECIFIED) TO DILATE THE AREA, AND 0.5 MG ATROPINE FOR RECOVERY OF PULSE AN

  Patient problems: No Code Available

  MAUDE report 8422370 ↗
• InjurySep 22, 2017Material Separation; Material Separation

  A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS USED IN A CAROTID INTERVENTION IN THE RIGHT GROIN VIA CONTRALATERAL APPROACH. IT WAS REPORTED THAT DURING REMOVAL OF THE SHEATH, THE TIP BROKE INSIDE OF THE PATIENT. A DILATOR WAS NOT INSERTED INTO THE SHEATH PRIOR TO REMOVAL. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO REMOVE THE TIP OF THE DEVICE. THE TIP WAS REMOVED SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6886013 ↗
• MalfunctionAug 10, 2017Material Separation; Material Separation

  A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT THE FELLOW PULLED THE SHEATH OUT OF THE PATIENT BY THE SIDE ARM AND THE ADAPTOR "POPPED OFF" THE SHEATH AT THE HUB (EVENT CAPTURED IN MEDWATCH WITH MANUFACTURER REPORT NUMBER 1820334-2017-02319). ADDITIONALLY, THE PHYSICIAN STATED THAT IT "HAPPENS ALL THE TIME" ALTHOUGH THIS IS THE FIRST TIME THE REP HAS WITNESSED AND/OR HEARD OF IT (EVENT CAPTURED IN MEDWATCH WITH MANUFACTURER REPORT NUMBER 1820334-2017-02485). NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY AND THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6785465 ↗
• MalfunctionMay 16, 2017Difficult to Insert; Split

  PRIOR TO PATIENT CONTACT, IT WAS NOTED THAT THERE WAS A SPLIT ON THE TIP OF THE SHEATH, SO IT COULDN'T BE INSERTED INTO THE VESSEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6570454 ↗
• MalfunctionMay 11, 2017Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER STATED THAT THERE WAS NO DAMAGE TO THE SHIPPING CONTAINER, BUT THE PACKAGING WAS FOUND TO BE RIPPED. UPON FURTHER REVIEW OF THIS PRODUCT PROBLEM, IT WAS NOTED THAT THE TORN DEVICE PACKAGE COMPROMISED THE STERILITY OF THE DEVICE. NO PATIENT INVOLVEMENT OR ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Patient Involvement

  MAUDE report 6561904 ↗
• InjuryMar 14, 2016Leak/Splash; Leak/Splash

  SIDEPORT VENTS LEAKED DURING A CAROTIS INTERVENTION 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 5497335 ↗