Flexor G12242Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002122420), received between Mar 30, 2016 and Jan 13, 2026 — classified as 1 injury, 18 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE WITH LEFT SUBCLAVIAN ARTERY (SCA) PLUG PLACEMENT, THE HEMOSTASIS VALVE OF A FLEXOR RAABE GUIDING SHEATH WAS FOUND TO BE BROKEN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055961 ↗
• MalfunctionOct 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 10NOV2025. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNSPECIFIED BRAND OF DEVICE THAT WAS AVAILABLE AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270694 ↗
• MalfunctionJul 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING STENT PLACEMENT WITHIN THE RIGHT FEMORAL ARTERY, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE DEVICE. PER THE REPORTER, THE SHEATH WAS DELIVERED TO THE TARGET LOCATION (RIGHT SUPERFICIAL FEMORAL ARTERY WHICH HAD STENOSIS AND TORTUOSITY). THE ACCESS SITE WAS NOT SCARRED. THE PATIENT HAD ARTERIAL STENOSIS OF THE LOWER EXTREMITIES. A CONTRALATERAL APPROACH WAS USED. THE BIFURCATION ANGLE WAS NOT STEEP, SHARP, OR CALCIFIED. RESISTANCE WAS NOT FELT DURING THE INSERTION OF THE DEVICE; HOWEVER, RESISTANCE WAS FELT DURING REMOVAL OF THE DILATOR. UPON ATTEMPTED REMOVAL OF THE DILATOR, THE HUB OF THE SHEATH SEPARATED. THE SHEATH WAS MANUALLY REMOVED FROM THE PATIENT, AND ANOTHER DEVICE OF THE SAME TYPE 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 22436875 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING SET UP FOR AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH'S HUB SEPARATED WHILE ATTEMPTING TO SHAPE THE DEVICE. THERE WAS NO HARM TO ANY PATIENT AS THIS OCCURRED BEFORE THE PATIENT ENTERED THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793206 ↗
• MalfunctionSep 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS ORIGINALLY REPORTED, UPON OPENING THE DEVICE PACKAGE PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE TIP OF A FLEXOR RAABE GUIDING SHEATH'S DILATOR WAS DAMAGED/"CRACKED". THE DEVICE WAS REPORTEDLY RECEIVED "IN PERFECT CONDITION". THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT. UPON PRELIMINARY INSPECTION OF THE RETURNED DEVICE, THE DISTAL TIP OF THE DILATOR WAS SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238264 ↗
• MalfunctionAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF STENOSIS OF THE ILIAC ARTERY, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING SHEATH WHILE ADVANCING THE DEVICE INTO THE PATIENT. THE ACCESS SITE WAS THE FEMORAL ARTERY WITHOUT SCARRING. THE PATIENT'S ANATOMY WAS REPORTEDLY, "SLIGHT TORTUOUS AND CALCIFIED". AN IPSILATERAL APPROACHED WAS USED. ANOTHER MANUFACTURER'S WIRE GUIDE WAS USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT USED FELT DURING INSERTION OR REMOVAL OF THE DEVICE OR DURING THE REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE HUB WAS NOT USED TO PULL THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951485 ↗
• MalfunctionApr 5, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2021. THE DEVICE WAS INSERTED VIA THE RIGHT COMMON FEMORAL ARTERY AND WAS IN PLACE FOR 45 MINUTES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 11614897 ↗
• MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ENDOVASCULAR PROCEDURE INVOLVING THE FEMORAL ARTERY, A FLEXOR RAABE GUIDING SHEATH WAS BEING ADVANCED TO THE LESION LOCATION WHEN THE HEMOSTATIC VALVE SEPARATED. THE SHEATH WAS THEN REMOVED AND REPLACED WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THIS DID NOT RESULT IN THE NEED FOR ANOTHER PROCEDURE OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712333 ↗
• MalfunctionJun 4, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING A DISTRIBUTOR INSPECTION OF A FLEXOR RAABE GUIDING SHEATH, AN UNKNOWN PARTICLE WAS DISCOVERED INSIDE THE PRIMARY PACKAGING OF THE PRODUCT. THIS DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10118617 ↗
• MalfunctionApr 5, 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 8488208 ↗
• MalfunctionJan 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE "SIDE PORT" DISCONNECTED FROM THE FLEXOR RAABE GUIDING SHEATH. THE COMPLAINT DEVICE WAS PLACED IN THE PATIENT'S GROIN. NO DAMAGE WAS NOTED AT THIS TIME. WHEN THE PHYSICIAN ATTEMPTED TO FLUSH THE COMPLAINT DEVICE, THE SIDE PORT DISCONNECTED. THE COMPLAINT DEVICE WAS THEN REMOVED AND THE PROCEDURE CONTINUED WITH A NEW SIMILAR DEVICE. PER THE INITIAL REPORTER, NO ADDITIONAL INFORMATION IS AVAILABLE. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8222006 ↗
• MalfunctionSep 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  A MALE PATIENT WITH HISTORY OF PERIPHERAL ARTERY DISEASE WAS UNDERGOING AN ANGIOPLASTY PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY (SFA). A FLEXOR RAABE GUIDING SHEATH WAS INSERTED IN THE LEFT GROIN FOR A CONTRALATERAL APPROACH TO THE CALCIFIED LESION IN THE RIGHT SFA. AFTER ADVANCING CATHETERS AND WIRES THROUGH THE SHEATH, IT WAS REPORTED THE CHECKFLO VALVE OF THE FLEXOR RAABE GUIDING SHEATH BECAME DISCONNECTED AT THE HUB. NO INFORMATION WAS PROVIDED REGARDING DIFFICULT ADVANCEMENT SUCH AS VESSEL TORTUOSITY OR SCARRING AT THE ACCESS SITE, BUT THERE WAS SOME CALCIFICATION NOTED. THE HYDROPHILIC COATING WAS ACTIVATED BY FLUSHING AND WIPING THE DEVICE AND WAS ACTIVATED THROUGH THE END OF THE PROCEDURE. AFTER THE DISCONNECTION, THE COMPLAINT DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW SHEATH. REPORTEDLY, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865146 ↗
• MalfunctionJul 13, 2018Detachment 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 Known Impact Or Consequence To Patient

  MAUDE report 7686883 ↗
• MalfunctionMar 12, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE HUB. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7331356 ↗
• InjuryNov 15, 2017Material Separation; Material Separation

  DURING A PERIPHERAL FEM-POP OCCLUSION PROCEDURE, THE FLEXOR RAABE GUIDING SHEATH WAS PLACED INSIDE OF THE PATIENT'S LEG USING A CONTRALATERAL APPROACH THROUGH VERY TORTUOUS ANATOMY. THE PHYSICIAN WAS ATTEMPTING TO REMOVE ANOTHER MANUFACTURER'S MECHANICAL THROMBECTOMY DEVICE THROUGH THE LUMEN OF THE OF THE FLEXOR RAABE GUIDING SHEATH, AND ADVANCED THE SHEATH. IT FELT TIGHT TO THE PHYSICIAN, AND THE CHECK-FLO VALVE CAME OFF. THE PHYSICIAN HAD TO REMOVE THE WIRE GUIDE AND ALTHOUGH HIS THUMB WAS PLACED OVER THE SHEATH WHERE THE CHECK-FLO VALVE CAME OFF, BLOOD LEAKED. THE WIRE GUIDE WAS THEN EXCHANGED FOR A LARGER WIRE GUIDE, AND THE FLEXOR RAABE GUIDING SHEATH WAS REPLACED WITH ANOTHER FLEXOR RAABE GUIDING SHEATH TO GO UP AND OVER THE BIFURCATION. THE PROCEDURE WAS THEN COMPLETED WITH NO FURTHER DIFFICULTIES. DUE TO THE BLOOD LOSS, WHICH WAS APPROXIMATELY 1100 CUBIC CENTIMETERS (CC), THE PATIENT REQUIRED A BLOOD TRANSFUSION DURING THE PROCEDURE. THE PHYSICIAN NOTED THE BIFURCATION WAS VERY TORTUOUS. THE DEVICE WILL NOT BE RETURNED, AS DUE TO THE FACILITY'S POLICY, THE PRODUCT WILL BE KEPT BY THE RISK MANAGEMENT DEPARTMENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING OKAY AND WAS

  Patient problems: Blood Loss

  MAUDE report 7035480 ↗
• MalfunctionSep 20, 2017Break; Material Separation; Break; Material Separation

  A FLEXOR RAABE GUIDING SHEATH WAS USED IN A VENOUS STENTING PROCEDURE IN A FEMORAL VEIN IN THE LEG, VIA CONTRALATERAL APPROACH. IT WAS REPORTED THAT WHEN REMOVING THE CATHETER, IT DAMAGED THE VALVES ON THE SHEATH AND IT "CAME A PART." IT IS BELIEVED THAT THE CATHETER PULLED THE DIAPHRAGM WHEN IT WAS REMOVED, CAUSING THE SHEATH DAMAGE. THE PROCEDURE WAS ABLE TO BE 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 Known Impact Or Consequence To Patient

  MAUDE report 6878703 ↗
• MalfunctionJan 4, 2017Material Separation; Material Separation

  IT WAS REPORTED AS THE PHYSICIAN WAS REMOVING THE SHEATH FROM THE PATIENT'S ANATOMY. THE CHECK-VALVE WAS SEPARATING 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 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 6222788 ↗
• MalfunctionJul 7, 2016Material Separation; Material Separation

  THE VALVE WAS DETACHED FROM THE SHEATH DURING THE PROCEDURE. THE USER FACILITY REPLACED THE DEVICE WITH A NEW DEVICE TO FINISH THE PROCEDURE. 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 5775921 ↗
• MalfunctionMar 30, 2016Material Separation; Material Separation

  INITIAL INFORMATION RECEIVED ON (B)(6) 2016: THE HUB SEPARATED FROM THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 08MAR2016 DETERMINED THIS EVENT TO BE REPORTABLE: THE PATIENT IS REPORTED TO HAVE HAD A CALCIFIED GROIN AND THE PROCEDURE LASTED APPROX. AN HOUR. UPON REMOVAL OF THE SHEATH, THE FLEXOR PORTION OF THE SHEATH SEPARATED FROM THE HUB. FORTUNATELY THE SHEATH WAS STILL ABLE TO BE REMOVED SAFELY. IT IS UNKNOWN IF THE BIFURCATION WAS TORTUOUS BIFURCATION OR NOT. 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 5535653 ↗