Flexor G50141Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002501416), received between Feb 2, 2017 and Jun 6, 2019 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2019Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED, A MALE PATIENT WAS UNDERGOING DILATATION AND STENTING OF THE SUPERFICIAL FEMORAL ARTERY BY WAY OF THE RADIAL ARTERY. ACCESS WAS OBTAINED USING ANOTHER MANUFACTURER'S INTRODUCER. THE VESSEL WAS FREE FROM CALCIFICATION AND WAS NOT TORTUOUS. DURING THE PROCEDURE, TWO FLEXOR SHUTTLE GUIDING SHEATHS BECAME DAMAGED. THE FIRST ONE KINKED AND HAD TO BE WITHDRAWN DUE TO DIFFICULTIES IN ADVANCING ALONG THE RADIAL AXIS, A NON-REPORTABLE EVENT. THE SECOND, ADVANCED NORMALLY ALONG THE RADIAL AXIS. UPON WITHDRAWAL, THIS SECOND FLEXOR SHUTTLE GUIDING SHEATH BECAME DIFFICULT TO REMOVE REQUIRING THE PHYSICIAN TO USE FORCE TO REMOVE IT. THE COMPLAINT SHEATH WAS REMOVED OVER ANOTHER MANUFACTURER'S WIRE GUIDE AFTER BEING IN PLACE FOR ONE HOUR; THE DILATOR WAS NOT INSIDE THE SHEATH. ARTERIAL SPASM WAS REPORTED AND A VASODILATOR WAS USED. THE SHEATH BROKE AND TORE APART INTO THREE PIECES DAMAGING THE ARTERY DURING REMOVAL. FURTHER CLARIFICATION WAS RECEIVED DESCRIBING THE DAMAGE AS THE PUNCTURE SITE WAS "VERY BIG". BLEEDING WAS NOTED BUT ESTIMATED BLOOD LOSS WAS NOT PROVIDED. THE PHYSICIAN USED ANOTHER MANUFACTURER'S CLOSING DEVICE FOR HEMOSTASIS. NO BLOOD TRANSFUSION WAS REQUIRED. NO I

  Patient problems: Hematoma; No Code Available; Perforation

  MAUDE report 8675635 ↗
• MalfunctionApr 9, 2018Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT WHILE ADVANCING THE FLEXOR SHUTTLE GUIDING SHEATH BY RADIAL PATH DURING AN UNSPECIFIED PROCEDURE, RESISTANCE WAS ENCOUNTERED DUE TO THE LACK OF SLIDING. THE CUSTOMER FELT THAT THERE WAS NO HYDROPHILIC COATING ON THE SHEATH. IT WAS NOTED THAT WITHDRAWAL OF THE SHEATH WAS DIFFICULT. THE SHEATH REPORTEDLY BROKE FIVE (5) CENTIMETERS (CM) FROM THE HUB WHILE OUTSIDE OF THE PATIENT'S ARTERY. ANOTHER FLEXOR SHUTTLE GUIDING SHEATH WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT EXPERIENCED TRAUMA TO THE ARTERY, AND A HEMATOMA. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING DETAILS OF THE PROCEDURE AND PATIENT OUTCOME HAVE BEEN REQUESTED; HOWEVER, ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7408259 ↗
• InjuryNov 10, 2017Component Missing; Component Missing

  DURING A RADIAL ARTERY PROCEDURE, THE FLEXOR SHUTTLE GUIDING SHEATH INTRODUCER HYDROPHILIC COATING WAS ABSENT, MAKING ITS MANIPULATION DIFFICULT TO HANDLE. IT WAS REPORTED THAT THERE WAS DIFFICULTY INTRODUCING THE DEVICE INTO THE RADIAL ARTERY, AND THE INTRODUCER WAS UNABLE TO BE WITHDRAWN. THE PATIENT'S RADIAL ARTERY WAS DISSECTED AND A HEMATOMA WAS FORMED; THE PATIENT REQUIRED STITCHES TO CLOSE THE ENTRANCE PORT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7022936 ↗
• MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material

  WHILE PREPARING MATERIAL TO PERFORM LEFT EXTERNAL AND PRIMITIVE ANGIOPLASTIES WITH STENT(S), THE DOCTOR TRIED TO PLACE THE DILATOR INSIDE THE SHEATH. HOWEVER, THE DOCTOR COULDN'T PROGRESS TO THE END OF THE SHEATH AND WAS ALSO UNABLE TO "CLIP" THE DILATOR ON THE VALVE OF THE SHEATH. THE DOCTOR NOTICED THAT THE DILATOR EXTREMITY WAS COVERED BY A "STRANGE STICKY SUBSTANCE," WHICH LOOKED LIKE GLUE. HE SUPPOSED IT WAS INSIDE THE SHEATH AND THE DILATOR WAS COVERED WITH THE SUBSTANCE UPON PASSING THROUGH THE SHEATH. AS A RESULT, HE WAS GIVEN A DIFFERENT DEVICE WITH THE SAME PART AND LOT NUMBER IN WHICH HE NOTED PRESENTED THE SAME PROBLEM- NO ABILITY TO JOIN THE DILATOR AND SHEATH TOGETHER TO ASSEMBLE THE INTRODUCER AND A STRANGE STICKY SUBSTANCE ON THE SHEATH WHICH CAME OUT DURING THE ATTEMPT TO PLACE THE DILATOR INSIDE THE SHEATH. THE COMPLAINANT REPORTED THAT THERE WAS ADVERSE EFFECTS ON THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM. HOWEVER, THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT AND NO ADVERSE EFFECTS WERE SPECIFIED.

  Patient problems: No Information

  MAUDE report 6590430 ↗
• MalfunctionFeb 2, 2017Difficult to Advance; Difficult to Advance

  IT WAS ALLEGED THAT THE INTRODUCER DEVICE WAS MISSING THE HYDROPHILIC COATING DURING THREE SEPARATE PROCEDURES. THE REPORTER STATED THAT THE ¿CARDIOLOGISTS WET THE INTRODUCER AND IT DID NOT SLIDE INSIDE.¿ THE INCIDENT REPORTEDLY RESULTED: NO HARM OR CONSEQUENCE TO THE PATIENT. (1820334-2017-00128). IN A COMPLICATION CAUSING THE PATIENT PAIN AND THE NEED FOR ANTALGIC MEDICINE. (1820334-2017-00123). INABILITY TO ADVANCE THE DEVICE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. (1820334-2017-00124). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6298094 ↗
• MalfunctionFeb 2, 2017Failure to Advance; Failure to Advance

  IT WAS ALLEGED THAT THE INTRODUCER DEVICE WAS MISSING THE HYDROPHILIC COATING DURING THREE SEPARATE PROCEDURES. THE REPORTER STATED THAT THE ¿CARDIOLOGISTS WET THE INTRODUCER AND IT DID NOT SLIDE INSIDE.¿ THE INCIDENT REPORTEDLY RESULTED: NO HARM OR CONSEQUENCE TO THE PATIENT. (1820334-2017-00128). IN A COMPLICATION CAUSING THE PATIENT PAIN AND THE NEED FOR ANTALGIC MEDICINE. (1820334-2017-00123). INABILITY TO ADVANCE THE DEVICE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. (1820334-2017-00124). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6297908 ↗
• InjuryFeb 2, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS ALLEGED THAT THE INTRODUCER DEVICE WAS MISSING THE HYDROPHILIC COATING DURING THREE SEPARATE PROCEDURES. THE REPORTER STATED THAT THE ¿CARDIOLOGISTS WET THE INTRODUCER AND IT DID NOT SLIDE INSIDE.¿ THE INCIDENT REPORTEDLY RESULTED: NO HARM OR CONSEQUENCE TO THE PATIENT. (1820334-2017-00128). IN A COMPLICATION CAUSING THE PATIENT PAIN AND THE NEED FOR ANTALGIC MEDICINE. (1820334-2017-00123). INABILITY TO ADVANCE THE DEVICE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. (1820334-2017-00124). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 6297027 ↗