Flexor G30117Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002301177), received between Jun 16, 2016 and Oct 3, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2023Break; Peeled/Delaminated; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Break; Peeled/Delaminated; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE INVOLVING THE SUPERFICIAL FEMORAL ARTERY (SFA), A FLEXOR ANSEL GUIDING SHEATH SEPARATED AND UNRAVELED. THE SHEATH WAS INSERTED FOR A CONTRALATERAL APPROACH TO TARGET THE SFA. ONCE THE SHEATH WAS OVER THE BIFURCATION, THE USER ADVANCED AN UNSPECIFIED CATHETER AND GUIDE WIRE DOWN THE SFA. AN UNKNOWN STIFF WIRE WAS USED DURING REMOVAL OF THE CATHETER. AFTER THE CATHETER WAS REMOVED, THE USER NOTICED THAT THE SHEATH WAS STUCK AND COULD NOT BE PULLED BACK. THE USER CONTINUED TO ATTEMPT TO REMOVE THE SHEATH; HOWEVER, THE HUB SEPARATED. FORCEPS WERE THEN USED TO SECURELY HOLD THE SHEATH AND THE USER CONTINUED TO PULL ON THE DEVICE, AT WHICH POINT IT UNRAVELED AND SEPARATED. PHOTOS PROVIDED BY THE CUSTOMER SHOW MULTIPLE AREAS OF UNRAVELING AND SEPARATION. AN OPEN SURGICAL PROCEDURE INVOLVING AN ARTERIAL CUTDOWN WAS PERFORMED TO REMOVE THE REMAINING PORTION OF THE SHEATH. THE PATIENT WAS HOSPITALIZED. NO FURTHER INTERVENTION WAS ATTEMPTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH WAS UNRAVELED, SEPARATED, AND DELAMI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860844 ↗
• InjuryOct 31, 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 9259968 ↗
• MalfunctionMay 16, 2017Failure to Advance

  THE COMPLAINANT ALLEGED THAT DILATOR WAS PLACED INSIDE THE SHEATH PRIOR TO ATTEMPTING TO PUT IT OVER THE WIRE. WHEN THE WIRE WAS INSIDE THE PATIENT, THE DISTAL TIP OF THE DILATOR WAS PARTIALLY CLOSED AND THE WIRE WOULD NOT GO THROUGH. THERE WAS ALSO AN ATTEMPT TO PASS THE WIRE THROUGH THE OTHER SIDE OF THE DILATOR. A DIFFERENT FLEXOR ANSEL GUIDING SHEATH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. UPON FURTHER REVIEW OF THIS PRODUCT PROBLEM, IT WAS NOTED THAT THE TIP OF THE DILATOR WAS SPLIT. THIS PRODUCT PROBLEM OCCURRED DURING A RENAL STENT AND THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6570568 ↗
• MalfunctionJan 31, 2017Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE SHEATH BEGAN TO UNCOIL UPON ADVANCEMENT INTO THE INFERIOR MESENTERIC ARTERY. THE PATIENT REMAINED UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6291596 ↗
• MalfunctionJun 16, 2016Material Separation; Material Separation

  DURING A LEG PROCEDURE, WHILE THE PHYSICIAN WAS REMOVING THE SHEATH, IT SEPARATED FROM THE HUB. THERE WAS ENOUGH OF THE DEVICE OUTSIDE OF THE PATIENT THAT THE PHYSICIAN WAS ABLE TO GRAB IT AND CONTINUE TO REMOVE FROM THE PATIENT BY HAND. NO HARM TO THE PATIENT AND NO OTHER DEVICES WERE USED AS THE PROCEDURE WAS COMPETED. 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 Consequences Or Impact To Patient

  MAUDE report 5728766 ↗