Flexor G48194Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002481947), received between Mar 8, 2016 and Feb 3, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionFeb 3, 2022Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, UPON COMPLETION OF AN INTERVENTIONAL PROCEDURE OF THE LEFT LEG, THE DISTAL TIP OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE, EXPOSING THE COILS. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET THE LEFT COMMON TIBIAL VESSEL. THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. AN UNKNOWN WIRE GUIDE, BALLOON, AND CATHETER WERE USED WITH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH, AND THE DILATOR WAS IN PLACE WHEN THE SEPARATION OCCURRED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. BECAUSE THE PROCEDURE WAS COMPLETE, ANOTHER DEVICE WAS NOT NEEDED. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH WAS FOUND TO HAVE UNRAVELED AND SEPARATED. 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 13440364 ↗
• MalfunctionJun 18, 2019Material Frayed; Material Frayed

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708211 ↗
• MalfunctionSep 8, 2017Material Frayed; Material Frayed

  A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, THE DEVICE WAS INSERTED INTO THE VESSEL BY RADIAL APPROACH WHEN IT WAS OBSERVED THE SHEATH TIP WAS "CURLED UP/BACK AND WAS FRAYED." ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6852737 ↗
• InjuryMar 16, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A VASCULAR ANGIOGRAM PROCEDURE USING A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH, WHEN THE USER BEGAN TO REMOVE THE CATHETER RESISTANCE WAS MET. THE EXTERNAL PORTION OF THE CATHETER AND SOME OF THE INTERNAL PORTION WERE REMOVED FROM THE PATIENT HOWEVER, FLUOROSCOPY SHOWED THAT A PORTION OF THE CATHETER REMAINED IN THE ARTERY. THE PATIENT WAS TAKEN TO SURGERY AND A CUT DOWN PROCEDURE WAS PERFORMED TO REMOVE THE REMAINING PORTION OF THE PRODUCT. STATEMENT FROM EMAIL: PATIENT HAD SUCCESSFUL REMOVAL OF SEVERED CATHETER COMPONENTS. WAS TRANSFERRED IN STABLE CONDITION TO A TERTIARY CARE CENTER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6411035 ↗
• InjuryMar 8, 2016Break; Difficult to Remove; Break; Difficult to Remove

  AT THE END OF A ARTERIOGRAPHY AND RIGHT ILIAC ANGIOPLASTY BY THE RIGHT RADIAL APPROACH PROCEDURE, IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER DUE TO A SPASM OF THE RADIAL ARTERY. THE INTRODUCER BROKE INTO SEVERAL PIECES. THE PATIENT UNDERWENT GENERAL ANESTHESIA TO REDUCE SPASM AND REMOVE THE INTRODUCER. THE REPORTER CONFIRMS THAT THE EVENT WAS LINKED TO THE ARTERY SPASM. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT铠BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTER TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5486606 ↗