Bentson PlusRecalls & reported problems across all models

We found 3 models of Bentson Plus by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2017 and Mar 17, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (5 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bentson Plus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Bentson Plus problems

Bentson Plus models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bentson Plus G09735

  WIRE, GUIDE, CATHETER
  1 recall9 reports
• Bentson Plus G09782

  WIRE, GUIDE, CATHETER
  1 recall3 reports
• Bentson Plus G10126

  WIRE, GUIDE, CATHETER
  1 report

Recent Bentson Plus adverse event reports

The 13 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  AS REPORTED, DURING A BELOW-THE-KNEE ANGIOPLASTY AND ATHERECTOMY, THE COATING OF A BENTSON PLUS FIXED CORE WIRE GUIDE CAME OFF OF THE DEVICE. THE DEVICE WAS ADVANCED VIA ANTEGRADE APPROACH FROM THE GROIN DOWN THE SUPERFICIAL FEMORAL ARTERY TO THE PEDAL ARTERY. ANOTHER MANUFACTURER'S CATHETER WAS ADVANCED OVER THE WIRE, AND THE WIRE WAS ATTEMPTED TO BE REMOVED TO EXCHANGE FOR A CROSSING WIRE. WHEN REMOVING THE WIRE, COATING WAS NOTED TO HAVE SCRAPED OFF A SMALL SECTION OF THE DISTAL END OF THE WIRE, AND THE TIP INTEGRITY WAS DEGRADED. THE WIRE WAS DIFFICULT TO REMOVE FROM THE CATHETER. A SMALL AMOUNT OF THROMBUS WAS PULLED BY THE WIRE. THE WIRE WAS EVENTUALLY ABLE TO BE COMPLETELY REMOVED FROM THE CATHETER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13790733 ↗
• MalfunctionMar 28, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8459891 ↗
• 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 ↗
• MalfunctionSep 19, 2018Device Damaged Prior to Use; Structural Problem; Material Twisted/Bent

  IT WAS REPORTED THAT 4 OF THE WIRES ARRIVED BENT, CAUSING THE COILS TO SEPARATE. NONE OF THESE WIRES MADE PATIENT CONTACT, SO THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER CONFIRMED THAT THEIR DISTAL SOLDER CONNECTIONS WERE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891479 ↗
• MalfunctionMar 27, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE WHEN REMOVING THE BENTSON PLUS FIXED CORE WIRE GUIDE FROM ITS PROTECTIVE HOLDER, THE PHYSICIAN'S GLOVE AND HAND WERE CUT BY A BARB ON THE WIRE. THE BARB WAS LOCATED NEAR THE TRANSITION OF THE STIFF WIRE TO THE FLEXIBLE END. THE PHYSICIAN CLEANED UP THE WOUND AND BANDAGED IT TO CONTINUE THE SCHEDULED PROCEDURE. THE PHYSICIAN DID NOT REQUIRE ANY PROCEDURE/ INTERVENTION DUE TO THIS OCCURRENCE.

  Patient problems: Tissue Damage

  MAUDE report 7373325 ↗
• 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 ↗

Other Cook Incorporated products

• Torcon NB79 models · 36 reports · 68 recalls
• Flexor134 models · 1,437 reports · 3 recalls
• Instinct5 models · 1,289 reports · 1 recall
• Saeed15 models · 863 reports
• Advance206 models · 816 reports
• Gunther Tulip5 models · 807 reports
• Hemospray2 models · 535 reports · 4 recalls
• NCircle10 models · 725 reports