Bentson Plus G09735Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002097353), received between Jul 18, 2017 and Nov 13, 2018 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 16, 2022Open, Classified

   Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

   Z-1825-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING AN ANGIOGRAM THE BENTSON PLUS FIXED CORE WIRE GUIDE SEPARATED. ACCORDING TO THE INITIAL REPORTER, ACCESS WAS GAINED USING AN UNSPECIFIED 19-GAUGE NEEDLE AND THE COMPLAINT DEVICE WAS ADVANCED THROUGH THE NEEDLE WITHOUT ISSUE. UPON REMOVING THE NEEDLE, ANOTHER MANUFACTURER'S SHEATH WAS PLACED OVER THE BENTSON PLUS FIXED CORE WIRE GUIDE. THE WIRE GUIDE WAS THEN REMOVED FROM THE SHEATH AND THE REPORTER NOTICED THERE WAS A SEPARATION IN THE WIRE. IT WAS STATED THAT THERE WAS NO RESISTANCE DURING THE REMOVAL OF THE WIRE. THE REPORTER STATED THE DETAILS OF THE PATENT'S ANATOMY AND WHETHER OR NOT THERE WAS ANY CALCIFICATIONS OF THE VESSEL IS UNKNOWN. 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 Consequences Or Impact To Patient

  MAUDE report 8063623 ↗
• MalfunctionOct 10, 2017Material Separation; Material Separation

  A BENTSON PLUS FIXED CORE WIRE GUIDE WAS USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, THE "CAP CAME OFF FLOPPY END". NO OTHER INFORMATION WAS PROVIDED. 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 6937502 ↗
• MalfunctionOct 10, 2017Material Deformation; Material Deformation

  A BENTSON PLUS FIXED CORE WIRE GUIDE WAS USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT THE INNER MANDRIL WAS STICKING OUT. NO OTHER INFORMATION WAS PROVIDED. 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 6937392 ↗
• MalfunctionOct 9, 2017Kinked; Material Separation; Kinked; Material Separation

  A BENTSON PLUS FIXED CORE WIRE GUIDE WAS USED DURING AN UNSPECIFIED "ANGIO" PROCEDURE. IT WAS REPORTED, THE WIRE HAD BEEN REMOVED FROM THE CATHETER AND WAS BEING WIPED DOWN WHEN THE TECH NOTICED SOMETHING ABNORMAL TOWARD THE END OF THE WIRE. IT WAS OBSERVED TO PULL APART EASILY. AS THE DEVICE WAS BLOODY IT WAS DISCARDED. A SECOND DEVICE WAS OPENED AND CHECKED BEFORE INSERTING IT INTO THE PATIENT. IT WAS DETERMINED TO BE ABNORMAL AS WELL SO IT WAS NOT USED. A THIRD WIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 6931804 ↗
• MalfunctionOct 9, 2017Material Deformation; Material Deformation

  A BENTSON PLUS FIXED CORE WIRE GUIDE WAS USED DURING AN UNSPECIFIED "ANGIO" PROCEDURE. IT WAS REPORTED THAT THE INNER MANDRIL WAS STICKING OUT. THE WIRE WAS REPORTEDLY BEING REMOVED THROUGH ANOTHER INSTRUMENT; HOWEVER, THE TYPE OF INSTRUMENT IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. 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 6931745 ↗
• MalfunctionAug 16, 2017Unraveled Material; Unraveled Material

  A BENTSON PLUS FIXED CORE WIRE GUIDE WAS USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT WHEN THE WIRE WAS FED BACK INTO THE CASING AND WAS WIPED DOWN, UNRAVELING WAS NOTICED. ANOTHER BENTSON PLUS FIXED CORE WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUE. 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 6798134 ↗
• MalfunctionAug 16, 2017Unraveled Material; Unraveled Material

  A BENTSON PLUS FIXED CORE WIRE GUIDE WAS USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT WHEN THE WIRE WAS WIPED DOWN, UNRAVELING WAS NOTICED AT THE DISTAL END. THEY STOPPED USING THE DEVICE AND THERE WAS NO HARM TO THE PATIENT. 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 6796663 ↗
• MalfunctionAug 11, 2017Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE OUTER COIL OF A BENTSON PLUS FIXED CORE WIRE GUIDE UNRAVELED DURING AN UNKNOWN PROCEDURE. IT IS UNKNOWN IF THIS WAS OBSERVED UPON REMOVAL FROM PACKAGE OR IF IT OCCURRED POST INSERTION INTO A 19 GAUGE NEEDLE WHILE PERFORMING A PROCEDURE USING SELDINGER TECHNIQUE 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 6789373 ↗
• MalfunctionJul 18, 2017Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT AFTER GETTING ACCESS WITH A 19UT GAGE NEEDLE VIA THE RIGHT FEMORAL ARTERY (FA), THE BENTSON PLUS FIXED CORE WIRE GUIDE WAS INSERTED. THE PHYSICIAN FELT RESISTANCE AND UPON WITHDRAWAL NOTED THAT THE TIP WAS UNRAVELING. ANOTHER BENTSON WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE EVENT OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723365 ↗