Flexor G29986Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002299863), received between Apr 21, 2016 and Sep 1, 2023 — classified as 4 injuries, 9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 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 17670683 ↗
• MalfunctionNov 10, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE TO TREAT PERIPHERAL ARTERY OCCLUSION IN THE RIGHT LEG AND USING A FLEXOR ANSEL GUIDING SHEATH, THE HUB CAP SEPARATED FROM THE SHEATH. AFTER BALLOON DILATION, THE PHYSICIAN BEGAN TO PULL BACK ON THE BALLOON AND DISCOVERED THE CHECK-FLO VALVE HAD SEPARATED, AND THERE WAS BLOOD LEAKING OUT. THEY USED A CLIP TO STOP THE BLOOD, AND THEN PULLED BACK ON THE SHEATH. THEY CHANGED TO ANOTHER DEVICE TO CONTINUE TO TREAT THE LESION BELOW THE KNEE. THE PATIENT DID NOT HAVE ANY TORTUOUS, SCARRED, OR CALCIFIED ANATOMY TO NOTE. THE SHEATH WAS IN PLACED FOR APPROXIMATELY 20 MINUTES. THE DILATOR WAS NOT IN PLACE WHEN THE SEPARATION OCCURRED. THERE WAS RESISTANCE FELT DURING INSERTION OR REMOVAL. THE PATIENT DID EXPERIENCE SOME BLOOD LOSS, BUT NO NEED FOR ADDITIONAL TREATMENT OR INTERVENTION. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789844 ↗
• MalfunctionFeb 27, 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 9765640 ↗
• MalfunctionFeb 27, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; 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 9765542 ↗
• MalfunctionNov 15, 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 9330165 ↗
• InjuryMar 27, 2019Material 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 Code Available

  MAUDE report 8457210 ↗
• MalfunctionJul 26, 2018Material Separation; Material Separation

  IT WAS REPORTED, THE FLEXOR ANSEL GUIDING SHEATH'S HUB SEPARATED DURING A ILIAC STENTING PROCEDURE. 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. 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 7722388 ↗
• MalfunctionDec 28, 2017Kinked; Split; Kinked; Split

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE FLEXOR ANSEL GUIDING SHEATH TIP WAS OBSERVED TO BE SPLIT/ KINKED. THE SHEATH DID NOT COME INTO CONTACT WITH A PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7151423 ↗
• MalfunctionJun 1, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, USING A FLEXOR ANSEL GUIDING SHEATH, THE CHECK-FLOW VALVE AND CATHETER WERE SEPARATED. THE PATIENT OUTCOME WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6605271 ↗
• InjuryDec 6, 2016Material Separation; Material Separation

  IT WAS REPORTED DURING THE EXCHANGE OF THE SHEATH FOR A SHORTER ONE THE HUB CAME OFF CAUSING UNNECESSARY BLEEDING DURING A PERIPHERAL INTERVENTION PROCEDURE. THE SHEATH WAS REPORTEDLY PLACED IN THE GROIN, A STIFF ANGLE GLIDE WIRE WAS BEING USED THROUGH THE SHEATH AND THE SEPARATION OCCURRED DURING REMOVAL. REPORTEDLY "THE FACILITY EXCHANGED THE SHEATH TO A NEW ONE TO COMPLETE THE PROCEDURE. THE BLOOD LOSS WAS MINIMAL AND BRIEF BLEEDING. THERE WAS NO ADVERSE CONSEQUENCE TO THIS EVENT. " 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: Blood Loss

  MAUDE report 6149048 ↗
• InjuryNov 16, 2016Material Separation; Material Separation

  IT WAS REPORTED THE PHYSICIAN WAS PERFORMING A PERIPHERAL CASE VIA GROIN ACCESS AND DURING THE EXCHANGE THE SHEATH SEPARATED FROM HUB. THE SHEATH WAS SUCCESSFULLY RETRIEVED WITH HEMOSTATS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS 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 6106581 ↗
• MalfunctionJul 26, 2016Material Separation; Material Separation

  IT WAS REPORTED UPON COMPLETION OF AN INTERVENTION OF A CONTRALATERAL SUPERFICIAL FEMORAL ARTERY (SFA) THE PHYSICIAN WAS PULLING THE SHEATH OUT WHEN THE HUB OF THE SHEATH SEPARATED FROM THE SHEATH. THE BIFURCATION WAS REPORTED TO BE NORMAL HOWEVER THE PHYSICIAN NOTED THE ACCESS SITE WAS EXTREMELY SCARRED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821994 ↗
• InjuryApr 21, 2016Material Separation; Material Separation

  UPON COMPLETION OF THE ANGIOGRAM THE FACILITY ATTEMPTED REMOVAL OF THE SHEATH. THE HUB SEPARATED FROM THE SHEATH WHICH RESULTED IN LOSS OF BLOOD. THE REMAINDER OF THE SHEATH WAS ABLE TO BE REMOVED. THE PATIENT IS FINE NO OTHER ADDITIONAL PROCEDURES WERE PERFORMED. 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: Blood Loss

  MAUDE report 5595976 ↗