Flexor G13091Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002130913), received between Nov 2, 2016 and Mar 2, 2026 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED 10MAR2026. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT GROIN. THE ACCESS SITE WAS NORMAL; HOWEVER, THE ANATOMY WAS STENOSED AND THE AORTA WAS CALCIFIED. REPORTEDLY, IT WAS A ¿LITTLE TRICKY¿ TO ADVANCE THE DEVICE OVER THE SEVERELY CALCIFIED AORTIC BIFURCATION DUE TO PLAQUE. A 0.018-INCH WIRE WAS USED DURING THE PROCEDURE, AS WELL AS ANOTHER MANUFACTURER¿S BALLOON. THE DILATOR WAS REINSERTED PRIOR TO SHEATH REMOVAL; HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE USER REMOVED THE SHEATH, AT WHICH POINT IT SEPARATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24483553 ↗
• MalfunctionJun 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM OF THE RIGHT LOWER EXTREMITY VIA CONTRALATERAL ACCESS IN THE LEFT GROIN TO TARGET THE RIGHT DISTAL POPLITEAL ARTERY, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE RIGHT DISTAL POPLITEAL ARTERY WAS STENOSED. THE BIFURCATION WAS NOT STEEP OR CALCIFIED. AN UNKNOWN MANUFACTURER¿S 0.035-INCH ¿ZIP¿ WIRE WAS USED DURING THE PROCEDURE, AND AN UNKNOWN CATHETER AND BALLOON WERE ALSO USED THROUGH THE SHEATH. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. UPON REMOVAL OF THE SHEATH OVER THE 0.035-INCH WIRE, THE HUB SEPARATED FROM THE DEVICE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH, WHICH WAS PULLED BY THE HUB AND SHAFT. THE SHEATH SHAFT WAS MANUALLY REMOVED FROM THE PATIENT AFTER THE HUB SEPARATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT, WHO IS REPORTEDLY ¿OK¿, 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 22212485 ↗
• MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEG, THE HUB OF A FLEXOR RAABE GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE OVER ANOTHER MANUFACTURER¿S WIRE, AND THE SHEATH BECAME STUCK IN THE PATIENT. CONTRALATERAL ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS SCARRED; HOWEVER, THE ANATOMY WAS REPORTEDLY NOT STENOSED, TORTUOUS, OR CALCIFIED, AND THE BIFURCATION WAS NOT STEEP. RESISTANCE WAS NOT ENCOUNTERED AS TWO COOK BALLOONS AND ONE OTHER MANUFACTURER¿S BALLOON WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT FELT UPON INSERTION OF THE SHEATH; HOWEVER, RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH. THE DILATOR WAS NOT REINSERTED PRIOR TO SHEATH REMOVAL, AND THE HUB WAS USED TO PULL THE SHEATH FROM THE PATIENT. THE USER WAS ABLE TO MANUALLY REMOVE THE SHEATH IN ITS ENTIRETY OVER THE WIRE GUIDE, WITHOUT PERFORMING A CUT-DOWN. A NEW SHEATH WAS PLACED, THE PROCEDURE WAS COMPLETED, AND ANOTHER MANUFACTURER¿S CLOSURE DEVICE WAS DEPLOYED. 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 22203154 ↗
• MalfunctionNov 19, 2024Unraveled Material; Unraveled Material

  AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE. A FLEXOR RAABE GUIDING SHEATH SEPARATED AS THE USER ATTEMPTED TO CURVE THE TIP OF THE DEVICE IN ORDER TO SHAPE IT FOR ¿UP AND OVER¿ ACCESS. THE SEPARATED TIP WAS HELD TOGETHER BY UNRAVELED COILS. THE DEVICE DID NOT MAKE PATIENT CONTACT. AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. 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 20725917 ↗
• InjurySep 7, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Anaphylactic Shock; Foreign Body In Patient

  MAUDE report 12435356 ↗
• MalfunctionAug 27, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021 CLARIFYING THAT THE SEPARATION OCCURRED ON THE SHAFT 8 TO 10 CENTIMETERS FROM THE HUB. THE DILATOR WAS NOT IN PLACE WHEN THE SEPARATION OCCURRED. THERE WAS NO RESISTANCE FELT DURING INSERTION OR REMOVAL AND EVERYTHING WAS REMOVED OVER THE WIRE. THE SHEATH WAS REPOSITIONED OVER A .035 WIRE AFTER THE WITHDRAW OF THE BALLOON TO GIVE IA MEDICATION (VASODILATOR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377606 ↗
• MalfunctionJun 29, 2021Material Separation; Material Separation

  AS REPORTED, A FLEXOR RAABE GUIDING SHEATH WAS BEING USED AND A COOK CATHETER BROKE WHILE INSIDE OF THE PATIENT. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085192 ↗
• InjuryJun 15, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999022 ↗
• MalfunctionAug 7, 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: No Consequences Or Impact To Patient

  MAUDE report 10381199 ↗
• MalfunctionJul 30, 2019Material Separation; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, A FLEXOR RAABE GUIDING SHEATH SEPARATED IN THE PATIENT UPON ATTEMPTED REMOVAL OF THE DEVICE. THE SEPARATED PORTION WAS ABLE TO BE REMOVED FROM THE PATIENT. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8841659 ↗
• MalfunctionMay 30, 2019Material Separation; Material Separation

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE LEFT POPLITEAL ARTERY INVOLVING AN (B)(6) MALE PATIENT WITH A HISTORY OF BILATERAL LOWER EXTREMITY STENTS AND BELOW-THE-KNEE AMPUTATION OF THE RIGHT LEG, A FLEXOR RAABE GUIDING SHEATH SEPARATED AT THE SHAFT. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY FOR A LEFT POPLITEAL INTERVENTION. THE PATIENT'S ANATOMY WAS REPORTED TO BE TORTUOUS, CALCIFIED, AND SCARRED; HOWEVER, RESISTANCE WAS NOT REPORTED. THE SHEATH WAS REPORTEDLY IN PLACE FOR TWO TO TWO-AND-ONE-HALF HOURS PRIOR TO REMOVAL. AS THE DEVICE WAS BEING REMOVED, IT BEGAN TO "BREAK INTO PIECES". THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL AND SEPARATION; HOWEVER AN UNKNOWN MANUFACTURER'S GUIDE WIRE WAS IN THE LUMEN AT THE TIME OF SEPARATION. THE DEVICE WAS ABLE TO BE REMOVED BY HAND. AN UNKNOWN MANUFACTURER'S ATHERECTOMY DEVICE AND BALLOON WERE USED DURING THE PROCEDURE. THE PATIENT'S OUTCOME HAS BEEN REPORTED AS "GOOD". 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8653780 ↗
• InjuryMay 7, 2019Material 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; No Code Available

  MAUDE report 8588294 ↗
• MalfunctionMar 5, 2019Unraveled Material; Unraveled Material

  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 8391489 ↗
• MalfunctionFeb 21, 2019Material Separation; Material Separation

  THE HHS/FDA SUS REPORT (MW5083236) WAS RECEIVED 07-FEB-2019. IT WAS REPORTED, A FLEXOR RAABE GUIDING SHEATH SEPARATED AT THE HUB WHILE PERFORMING A SHEATH EXCHANGE. NO INFORMATION WAS PROVIDED INDICATING MEDICAL INTERVENTION WAS PROVIDED OR THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT BUT HAS NOT YET BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358220 ↗
• MalfunctionJan 17, 2019Detachment of Device or Device Component

  SHEATH SEPARATED AT THE HUB WHILE PERFORMING SHEATH EXCHANGE.

  Patient problems: No Information

  MAUDE report 8261087 ↗
• InjuryJul 27, 2017Material Separation; Material Separation

  IT IS ALLEGED THAT A FLEXOR RAABE GUIDING SHEATH WAS BEING USED FOR A LEFT-LEG ANGIO FOR THE TIBIALS WHEN THE SHEATH SEPARATED. IT WAS REPORTED THAT AS THE SHEATH WAS BEING EXCHANGED AT THE END OF THE CASE, THE "CHECK-FLO" CAME OUT BUT THE REMAINDER OF THE SHEATH WAS LEFT IN THE PATIENT. THE COMPLAINANT CONTINUES THAT THE PATIENT REQUIRED AN ADDITIONAL SURGERY FOR REMOVAL, WHICH WAS DEEMED SUCCESSFUL AS THE DEVICE WAS REMOVED AND THE INITIAL PROCEDURE WAS COMPLETED.

  Patient problems: No Code Available

  MAUDE report 6747118 ↗
• MalfunctionMay 16, 2017Break; Device Operates Differently Than Expected

  THE TIP OF THE DILATOR WAS DAMAGED, WHICH PREVENTED THE WIRE FROM INITIALLY PASSING THROUGH IT. THE DEVICE WAS NOT USED ON THE PATIENT. 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 6569245 ↗
• InjuryNov 2, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT DURING REMOVAL OF FLEXOR RAABE GUIDING SHEATH WHILE UNDERGOING AN ANGIOGRAM RUNOFF PROCEDURE, THE SHEATH TIP SEPARATED AT 40 CENTIMETERS (CM) AFTER BEING PLACING ABOVE THE ILIAC BIFURCATION. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN TIP; HOWEVER, THE PATIENT SUBSEQUENTLY REQUIRED AN ABOVE THE KNEE AMPUTATION (AKA). THE TREATING PHYSICIAN FURTHER REPORTED THAT IT IS UNKNOWN IF THE AMPUTATION WAS A RESULT OF THE REPORTED EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6072354 ↗