Flexor G11636Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00827002116368), received between Jul 26, 2016 and May 12, 2026 — classified as 13 injuries, 26 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED LOWER EXTREMITY PROCEDURE VIA ACCESS IN THE RIGHT BRACHIAL ARTERY, A FLEXOR RAABE GUIDING SHEATH LEAKED. AFTER INSERTION OF THE SHEATH, THE ¿LOCKING BUCKLE AT THE CONNECTION BETWEEN THE SHEATH EXTENSION TUBE AND THE MAIN SHEATH BODY¿ DETACHED, RESULTING IN INTRAOPERATIVE BLEEDING. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT STENOSED, CALCIFIED, OR TORTUOUS. PER THE REPORTER, THE CLEAR SIDE-ARM TUBING DID NOT SEPARATE FROM THE HUB. THE SHEATH TUBING DID NOT SEPARATE FROM THE HUB. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION AND/OR ADVANCEMENT OF THE SHEATH NOR DURING INSERTION/ADVANCEMENT OF ANY DEVICE THROUGH THE SHEATH. THE DILATOR WAS IN PLACE AT THE TIME OF THE EVENT. THE SHEATH, WHICH WAS REMOVED IMMEDIATELY, WAS REPLACED WITH ANOTHER VASCULAR 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151653 ↗
• MalfunctionFeb 10, 2026Unraveled Material

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH "SNAPPED" AND UNRAVELED UPON REMOVAL OF THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305992 ↗
• MalfunctionSep 23, 2025Break; Unraveled Material; Break; Unraveled Material

  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 23126409 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ¿ANGIO¿ OF THE LEG VIA A CONTRALATERAL APPROACH, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE, WITH THE DILATOR IN PLACE. THE ANATOMY WAS REPORTEDLY VERY TORTUOUS AND TIGHT, AND THE BIFURCATION WAS STEEP AND/OR CALCIFIED. AN UNSPECIFIED COOK 635 STENT WAS USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED DURING INSERTION AND/OR REMOVAL OF THE SHEATH. THE SHEATH WAS PULLED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTEDLY ¿FINE¿. 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 22631858 ↗
• MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A BELOW-THE-KNEE INTERVENTIONAL PROCEDURE INVOLVING THE RIGHT LEG, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY, AND THE ACCESS SITE WAS VERY SCARRED. THE ANATOMY WAS SCARRED FROM MULTIPLE INTERVENTIONAL PROCEDURES. RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF THE SHEATH. THE HUB REPORTEDLY POPPED OFF THE SHEATH AS THE SHEATH WAS PULLED BACK TO REMOVE ACCESS. THE SHEATH SHAFT WAS REMOVED MANUALLY FROM THE PATIENT. THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. 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 21729524 ↗
• MalfunctionMar 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, UPON COMPLETION OF AN ANGIOGRAM, THE HUB SEPARATED FROM A FLEXOR RAABE GUIDING SHEATH UPON REMOVAL OF THE DEVICE FROM THE PATIENT. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT GROIN TO TARGET THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS SITE WAS NOT SCARRED, AND THE BIFURCATION WAS NOT STEEP OR CALCIFIED. PER THE REPORTER, ¿SOME¿ CALCIFICATION WAS NOTED IN THE SFA. ANOTHER MANUFACTURER¿S LASER ATHERECTOMY DEVICE WAS USED THROUGH THE SHEATH, AS WELL AS AN UNSPECIFIED COOK BALLOON AND AN UNKNOWN DRUG-COATED BALLOON. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH, NOR UPON INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH OVER AN UNKNOWN WIRE GUIDE. THE SHEATH HUB WAS USED TO PULL THE SHEATH FROM THE PATIENT, AT WHICH POINT THE HUB SEPARATED. THE SHEATH SHAFT WAS REMOVED ENDOVASCULARLY. 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 21547806 ↗
• MalfunctionJan 20, 2025Break; Break

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEG, A FLEXOR RAABE GUIDING SHEATH SEPARATED. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET THE SUPERFICIAL FEMORAL ARTERY. THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. AT THE BEGINNING OF THE PROCEDURE, RESISTANCE WAS ENCOUNTERED UPON INSERTION AND ADVANCEMENT OF THE SHEATH, AND BECAUSE THE SHEATH WAS DIFFICULT TO ADVANCE, THE PHYSICIAN REPORTEDLY USED ¿EXTRA FORCE¿. AN UNKNOWN INTRAVASCULAR LITHOTRIPSY DEVICE WAS USED DURING THE PROCEDURE, AS WELL AS MULTIPLE WIRE GUIDES. AT THE END OF THE CASE, THE USER ATTEMPTED TO REMOVE THE SHEATH OVER ANOTHER MANUFACTURER¿S WIRE; HOWEVER, APPROXIMATELY ONE-THIRD OF THE DISTAL END/TIP OF THE SHEATH SEPARATED IN THE PATIENT. THE DILATOR WAS NOT REINSERTED PRIOR TO ATTEMPTED REMOVAL OF THE SHEATH. ACCESS WAS OBTAINED CONTRALATERALLY, AND AN UNSPECIFIED GOOSENECK SNARE WAS USED TO RETRIEVE THE SEPARATED FRAGMENT FROM THE PATIENT. 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 21190960 ↗
• MalfunctionNov 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING THROMBOLYSIS VIA A FEMORAL ARTERY PUNCTURE, A FLEXOR RAABE GUIDING SHEATH'S VALVE LEAKED WHILE PASSING AN UNKNOWN MANUFACTURER'S .035'' WIRE GUIDE THROUGH THE SHEATH. RESISTANCE WAS NOT FELT UPON INSERTION/REMOVAL OF THE WIRE GUIDE THROUGH THE SHEATH. THE SHEATH WAS REMOVED, AND ANOTHER DEVICE WAS USED. THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS 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 THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613218 ↗
• MalfunctionOct 29, 2024Detachment 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 20556041 ↗
• MalfunctionNov 14, 2023Break; Peeled/Delaminated; Unraveled Material; Break; Peeled/Delaminated; Unraveled Material

  AS REPORTED, DURING AN ANGIOGRAM OF THE LOWER EXTREMITY, A FLEXOR RAABE GUIDING SHEATH UNRAVELED AND SEPARATED UPON REMOVAL OF THE DEVICE. RETROGRADE ACCESS WAS OBTAINED IN THE LEFT DISTAL COMMON FEMORAL ARTERY, USING A COOK MICROPUNCTURE DEVICE, AND A CONTRALATERAL APPROACH WAS USED TO TARGET THE RIGHT LOWER SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE PATIENT'S ANATOMY WAS HEAVILY CALCIFIED AND SEVERELY OCCLUDED, AND THE BIFURCATION ANGLE WAS STEEP. RESISTANCE WAS ENCOUNTERED UPON INSERTION AND REMOVAL OF THE COMPLAINT DEVICE, WITH THE PHYSICIAN REPORTING THAT SHE HAD TO PUSH MORE THAN NORMAL. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF WIRES, CATHETER, SHEATH, AND AN ATHERECTOMY DEVICE THROUGH THE COMPLAINT DEVICE. ALTHOUGH ANOTHER MANUFACTURER'S LASER ATHERECTOMY DEVICE WAS USED THROUGH THE SHEATH, IT WAS REPORTEDLY NOT ACTIVATED WITHIN THE SHEATH. THE DILATOR WAS NOT REINSERTED PRIOR TO SHEATH REMOVAL, AT WHICH POINT THE SHEATH UNRAVELED AND SEPARATED. PHOTOS PROVIDED BY THE CUSTOMER SHOW UNRAVELING, SEPARATION, AND POSSIBLE DELAMINATION OF THE SHEATH. ACCESS WAS THEN OBTAINED IN THE LEFT DISTAL COMMON ILIAC ARTERY AND A BALLOON W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131219 ↗
• MalfunctionNov 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING ANGIOGRAPHY WITH EMBOLIZATION OF AN ANEURYSM, A FLEXOR RAABE GUIDING SHEATH LEAKED. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET THE SUPERIOR BRACHIAL ARTERY. ANOTHER MANUFACTURER'S 5-FRENCH SHEATH AND 260-CENTIMETER WIRE WERE USED THROUGH THE COOK SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. THE WIRE GUIDE WAS IN THE LUMEN AT THE TIME OF THE LEAK. A NEW SHEATH WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18075117 ↗
• MalfunctionOct 11, 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 17914459 ↗
• InjuryAug 15, 2023Break; Unraveled Material; Break; Unraveled Material

  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 17548395 ↗
• MalfunctionJun 14, 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 17126839 ↗
• MalfunctionFeb 10, 2023Break; Material Puncture/Hole; Material Split, Cut or Torn; Break; Material Puncture/Hole; Material Split, Cut or Torn

  AS REPORTED, UPON REMOVAL OF THE DEVICE DURING AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH WAS DEFORMED AND "PERFORATED". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 16353497 ↗
• MalfunctionJul 27, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, PRIOR TO PATIENT CONTACT AND DURING A PROCEDURE INVOLVING EMBOLIZATION OF AN INTRACRANIAL ANEURYSM IN A PREVIOUSLY HOSPITALIZED PATIENT, THE TIP OF A FLEXOR RAABE GUIDING SHEATH WAS FOUND TO BE SEPARATED. THE SEPARATED TIP WAS FOUND WHEN THE USER OPENED THE DEVICE PACKAGING; THEREFORE, THE DEVICE WAS NOT USED. THE DEVICE WAS REPLACED WITH ANOTHER SHEATH, AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111640 ↗
• InjuryMay 7, 2022Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED, DURING A FEMORAL ANGIOGRAM OF THE RIGHT LEG, THE MIDDLE OF A FLEXOR RAABE GUIDING SHEATH UNRAVELED AND SEPARATED IN THE PATIENT. SCARRING AND PLAQUE WERE REPORTED AT THE LEFT GROIN ACCESS SITE. AFTER THE SHEATH SEPARATED, THE PHYSICIAN OBTAINED ACCESS LOWER IN THE LEG AND USED AN UNSPECIFIED BALLOON DEVICE TO PUSH THE SHEATH UP TO RETRIEVE IT. THE SHEATH WAS REMOVED IN ITS ENTIRETY. THE DILATOR WAS NOT IN PLACE AT THE TIME OF SEPARATION. THE PROCEDURE WAS COMPLETED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14322792 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED 21NOV2021: THE GROIN WAS THE INTENDED ACCESS SITE. THE SHEATH WAS IN PLACE APPROXIMATELY 30 MINUTES. THERE WERE NO ADDITIONAL MEANS OF INTERVENTION AS A RESULT OF THIS EVENT. THE PATIENT DID NOT EXPERIENCE ANY SIGNIFICANT BLOOD LOSS.

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

  MAUDE report 12646844 ↗
• MalfunctionApr 5, 2021Material Separation; Detachment of Device or Device Component; Material Separation; 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 11614114 ↗
• MalfunctionSep 25, 2020Defective Device; Defective Device

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10587097 ↗
• MalfunctionSep 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10484012 ↗
• InjuryMar 12, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Laceration(s)

  MAUDE report 9825783 ↗
• InjuryMar 5, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 9795028 ↗
• InjuryJan 27, 2020Break; Fracture; Difficult to Remove

  FEMALE WITH PAST MEDICAL HISTORY SIGNIFICANT FOR DIABETES, OBESITY, HYPERTENSION, STRONG FAMILY HISTORY OF HEART DISEASE, EX-SMOKER, WHO PRESENTED WITH SUDDEN ONSET OF CHEST PAIN. WHILE PERFORMING AN ANGIOGRAPHY, FLEXOR CHECK FLO INTRODUCER RAABE SHEATH'S WIRE UNCOILED FROM SHEATH WHEN REMOVING. WIRE CUT PHYSICIANS HAND AND WAS LEFT INSIDE PATIENT'S RIGHT ARM. PATIENT REQUIRED ADDITIONAL SURGERY TO HAVE WIRE REMOVED. "WE HAD DIFFICULTY IN TAKING OUT SHEATH AND PATIENT WAS HEAVILY SEDATED DESPITE OF THE FACT THERE WAS DIFFICULTY IN TAKING OUT THE SHEATH. WE GAVE NITRO BOLUSES AND PULL THE SHEATH UP TO AXILLARY FROM ASCENDING AORTA AND PULL THE SHEATH AGGRESSIVELY WHILE THE PATIENT WAS ADEQUATELY PAIN CONTROLLED. HOWEVER, WE NOTICED THAT SHEATH BROKE/FRACTURED. AFTER THE BREAKING OF THE SHEATH THERE WAS A SEGMENT OF SHEATH THAT WAS LEFT IN THE AXILLARY ARTERY. WIRE WAS ALSO SEEN COMING OUT OF THE VESSEL/ RADIAL ARTERY WHICH WAS PULLED, BUT THERE WAS STILL RESIDUAL WIRE LEFT IN THE RADIAL ARTERY. WE CALLED THE VASCULAR SURGEON ON CALL AND PATIENT WILL BE TAKEN TO THE OPERATING ROOM.

  Patient problems: Laceration(s)

  MAUDE report 9631508 ↗
• InjuryDec 31, 2019Material Separation; Unraveled Material; Material Separation; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 9535642 ↗