Flexor G30009Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002300095), received between Jun 7, 2016 and Mar 26, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  AS REPORTED, DURING A PROCEDURE INVOLVING BALLOON ANGIOPLASTY OF THE TIBIAL ARTERY, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED AT THE HUB UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE PATIENT WAS HEPARINIZED AND CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT GROIN. THE ANATOMY, INCLUDING THE ACCESS SITE AND THE AORTIC BIFURCATION, WAS CALCIFIED. MINIMAL RESISTANCE WAS ENCOUNTERED UPON INSERTION/ADVANCEMENT OF THE SHEATH AND DURING INSERTION/ADVANCEMENT OF OTHER DEVICES THROUGH THE SHEATH. PER THE REPORTER, HALF-WAY THROUGH THE CASE, WHILE ATTEMPTING TO RETRACT THE SHEATH A ¿SHORT DISTANCE¿ BY PULLING THE SHEATH BY THE HUB, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE SHEATH BROKE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL. ANOTHER MANUFACTURER¿S 5-MILLIMETER BALLOON CATHETER WAS IN THE SHEATH LUMEN AT THE TIME OF THE EVENT. THE COMPLAINT DEVICE WAS EXCHANGED FOR A 5-FRENCH COOK FLEXOR ANSEL SHEATH. 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH WAS SEPARATED JUST BELOW THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705748 ↗
• MalfunctionDec 3, 2025Detachment 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 23708062 ↗
• MalfunctionSep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 18SEP2025 STATING THAT THE DEVICE WOULD BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083487 ↗
• MalfunctionJan 23, 2024

  AT THE END OF THE PROCEDURE. THE 5FR 90CM SHUTTLE SHEATH WAS EXCHANGE FOR A SHORTER SHEATH. DURING THE EXCHANGE THE SHUTTLE SHEATH ELONGATED AND BROKE INTO THREE PIECES. THE SHEATH WAS ABLE TO BE RETRIEVE AND REMOVE. POST ANGIOGRAM SHOWED NO DISSECTION OR EXTRAVASATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563089 ↗
• MalfunctionAug 16, 2023Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  AS REPORTED BY A DISTRIBUTOR, UPON UNPACKING A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH IN A WAREHOUSE, A HAIR WAS FOUND INSIDE THE STERILE DEVICE PACKAGE. THIS OCCURRED WITHIN A DISTRIBUTION FACILITY. THERE WAS NO IMPACT TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557703 ↗
• MalfunctionMay 12, 2023Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING OCCLUSIVE PERIPHERAL ARTERY DISEASE OF THE LEFT LEG, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH UNRAVELED AND SEPARATED. ACCESS WAS OBTAINED IN THE SUPERFICIAL FEMORAL ARTERY FOR A CONTRALATERAL APPROACH. THE ACCESS SITE WAS NOT SCARRED, THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED, AND THE BIFURCATION ANGLE WAS NOT STEEP. ANOTHER MANUFACTURER'S 0.035-INCH, 300-CENTIMETER HEAVY DUTY WIRE WAS USED DURING THE PROCEDURE, AS WELL AS ANOTHER MANUFACTURER'S FIVE-MILLIMETER BALLOON. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH, OR DURING ADVANCEMENT OR REMOVAL OF OTHER DEVICES THROUGH THE SHEATH. AFTER BALLOON DILATION, THE USER ATTEMPTED TO PULL THE SHEATH BACK BY THE HUB, WHILE LEAVING THE BALLOON CATHETER IN PLACE; HOWEVER, THE SHEATH SEPARATED AT THE LEVEL OF THE HUB AND ALSO UNRAVELED AND SEPARATED FURTHER DOWN THE SHEATH. THE USER THEN SLOWLY PULLED THE SHEATH AND BALLOON CATHETER FROM THE PATIENT AT THE SAME TIME, AND THE PROCEDURE WAS COMPLETED. THE DILATOR WAS NOT IN PLACE AT THE TIME OF SEPARATION/UNRAVELING, AS THE BALLOON CATHETER WAS STILL IN THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921313 ↗
• MalfunctionAug 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HUB ON A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS SEPARATED FROM THE SHEATH AFTER BALLOON DILATION. THE SHEATH WAS REMOVED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293968 ↗
• InjuryMar 23, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED AT BOTH THE HUB AND SHAFT UPON REMOVAL OF THE DEVICE. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY TO TARGET THE TIBIAL VESSELS. THE RIGHT COMMON ILIAC ARTERY WAS REPORTEDLY HEAVILY CALCIFIED, AND THE TIBIAL VESSELS WERE DESCRIBED AS HAVING MULTI-LEVEL DISEASE. THE PHYSICIAN INTENDED TO STENT THE COMMON ILIAC WITH AN UNKNOWN STENT; HOWEVER, THIS WAS NOT POSSIBLE, AS THE STENT ¿WOULD NOT COME OUT¿. AN UNKNOWN ANGIOPLASTY BALLOON WAS USED DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED AS THE USER ATTEMPTED TO REMOVE THE SHEATH; HOWEVER, THE DILATOR WAS NOT REINSERTED INTO THE SHEATH. AS THE USER PULLED THE SHEATH, THE HUB AND SHEATH SEPARATED, LEAVING A PORTION OF THE SHEATH IN THE RIGHT FEMORAL ARTERY. THE PATIENT WAS TAKEN TO SURGERY FOR A CUT-DOWN PROCEDURE, AND THE SEPARATED PORTION OF THE SHEATH WAS REMOVED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. PER THE REPORTER, THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13868926 ↗
• MalfunctionJan 13, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING AN ANGIOGRAM AND ANGIOPLASTY OF THE LEFT LOWER LEG, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED AND UNRAVELED. THE DEVICE WAS INSERTED INTO THE RIGHT COMMON FEMORAL ARTERY VIA A CALCIFIED AND SCARRED GROIN, USING THE 0.038 DILATOR, OVER ANOTHER MANUFACTURER'S 0.035-INCH WIRE GUIDE. RESISTANCE WAS REPORTED. THE DILATOR WAS REMOVED AND ANGIOPLASTY WAS PERFORMED WITHIN THE LEFT POSTERIOR TIBIAL ARTERY, USING AN UNKNOWN BALLOON. THE SHEATH WAS ADVANCED TO THE LEFT POPLITEAL ARTERY. AT SOME POINT DURING THE PROCEDURE, THE USER REPORTEDLY REMOVED THE TUOHY-BORST VALVE FROM THE SHEATH AND ADDED A CHECK-FLO VALVE TO THE DEVICE. UPON COMPLETION OF ANGIOPLASTY, THE VASCULAR RESIDENT PULLED THE SHEATH BACK BY THE HUB. THE DEVICE WAS REMOVED OVER THE WIRE; HOWEVER, THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL. "HEAVY" RESISTANCE WAS ENCOUNTERED AS THE USER PULLED THE SHEATH BACK, AND THE CHECK-FLO VALVE AND "REAR" OF THE SHEATH SEPARATED OUTSIDE OF THE PATIENT'S BODY. THE USER CONTINUED TO PULL THE SHEATH BACK, PULLING THE WIRE AT THE SAME TIME; HOWEVER, RESISTANCE CONTINUED AND ANOTHER SEGMENT OF THE SHEATH BEGAN TO UNRAVEL AND SEPARATE OUTSIDE OF THE BODY. THE REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253207 ↗
• MalfunctionFeb 11, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED ON 17FEB2021: THE PROCEDURE BEING PERFORMED WAS A BRACHIAL THROMBECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11314756 ↗
• InjuryJan 18, 2021Material Separation; Unraveled Material; Detachment of Device or Device Component; Material Separation; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE OF THE LOWER LEG, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED AT THE HUB AND SHAFT. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND THE SHEATH WAS ADVANCED NINETY CENTIMETERS, OVER THE BIFURCATION, TO THE RIGHT POPLITEAL ARTERY. THE ANATOMY WAS REPORTEDLY TORTUOUS AND CALCIFIED. AT THE END OF THE PROCEDURE, AS THE PHYSICIAN ATTEMPTED TO EXCHANGE THE COMPLAINT DEVICE FOR A SHORTER SHEATH OVER ANOTHER MANUFACTURER'S WIRE, THE HUB SEPARATED FROM THE SHEATH, AND THE SHAFT CONTINUED TO SEPARATE AND UNRAVEL AS THE DEVICE WAS PULLED FROM THE PATIENT. RESISTANCE WAS REPORTED TO BE "JUST AS ANY OTHER CASE". PER THE REPORTER, IT IS POSSIBLE THAT THE HUB OF THE SHEATH WAS USED TO PULL THE DEVICE FROM THE PATIENT AND THE HUB CAME OFF IN ANOTHER MANUFACTURER'S BLEED-BACK CONTROL VALVE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH AND WAS THEREFORE NOT IN PLACE AT THE TIME OF SEPARATION. A VASCULAR SURGEON WAS CALLED TO PERFORM A CUT DOWN PROCEDURE TO REMOVE THE ENTIRE SHEATH FROM THE PATIENT. VERY MINIMAL BLOOD LOSS WAS REPORTED, AND THE PATENT'S OUTCOME WAS REPORTED AS GOOD. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIEN

  Patient problems: No Code Available

  MAUDE report 11187000 ↗
• MalfunctionJun 5, 2019Fluid/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 Consequences Or Impact To Patient

  MAUDE report 8670028 ↗
• MalfunctionDec 11, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  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 8151257 ↗
• MalfunctionMay 15, 2017Dull, Blunt; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN ATTEMPTING TO ADVANCE THE SHEATH DOWN INTO THE LEFT SFA, THE DILATOR SEEMED TO BE GETTING HUNG IN THE AORTA. SUBSEQUENTLY, THE DILATOR WAS REMOVED AND THE SHEATH WAS ADVANCED WITHOUT THE DILATOR TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT AFTER THE PROCEDURE, UPON EXAMINING THE DILATOR, THE TIP/TAPER OF THE DILATOR WAS NOTED TO NOT "SEEM TO BE RIGHT" AS PER THE CUSTOMER, THE TIP WAS USUALLY MORE OF A POINT BUT THE TIP OF THIS DILATOR WAS MORE UNIFORMED. WHEN A COMPARISON WAS DONE BETWEEN THE .035 DILATOR AND THE .018 DILATOR, THERE WAS A DIFFERENCE IN THE TIPS. VISUAL INSPECTION IDENTIFIED THE .035 DILATOR TAPER WAS BLUNT AND INADEQUATE. 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 6567295 ↗
• MalfunctionJun 16, 2016Break; Break

  UPON RETRACTING THE SHEATH DURING A LEFT LEG ANGIOPLASTY PROCEDURE ON THE MALE PATIENT, THE HUB BROKE. THE SHEATH WAS ABLE TO BE REMOVED BY HAND. 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 5728578 ↗
• MalfunctionJun 7, 2016Unraveled Material; Unraveled Material

  AORTOGRAM, RIGHT LEG ANGIOGRAM, RIGHT TIBIAL ARTERY BALLOON ANGIOPLASTY PROCEDURE WAS BEING PERFORMED ON THE (B)(6) FEMALE PATIENT; WITH PRE-EXISTING CONDITION OF RIGHT LEG PAD WITH CLAUDICATION AND A TORTUOUS ANATOMY. DURING THE REMOVAL OF THE 5FR SHUTTLE SHEATH, THE MID PORTION OF THE SHEATH UNRAVELED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 5702963 ↗