ETHICON VSTL45Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031462724), received between Jun 3, 2020 and Sep 23, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED TO THE SALES REP THAT ON 9/19/2025 THE CUSTOMER RECEIVED FOUR BOXES, EACH WITH THE CORRECT PRODUCT CODE LABEL. HOWEVER, THE ITEMS INSIDE THE BOXES WERE INCORRECT. THE CUSTOMER ORDERED PRODUCT CODE FOR THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR, BUT THE ACTUAL ITEMS RECEIVED WERE LAPAROSCOPIC DUAL RIGID APPLICATOR. THE BOXES THEMSELVES ARE CORRECTLY LABELED, BUT THE CONTENTS DO NOT MATCH THE ORDERED PRODUCT, RESULTING IN THE CORRECT BOXES CONTAINING THE WRONG ITEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121254 ↗
• MalfunctionSep 23, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED TO THE SALES REP THAT ON (B)(6) 2025, THE CUSTOMER RECEIVED FOUR BOXES, EACH WITH THE CORRECT PRODUCT CODE LABEL. HOWEVER, THE ITEMS INSIDE THE BOXES WERE INCORRECT. THE CUSTOMER ORDERED PRODUCT CODE FOR THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR, BUT THE ACTUAL ITEMS RECEIVED WERE LAPAROSCOPIC DUAL RIGID APPLICATOR. THE BOXES THEMSELVES ARE CORRECTLY LABELED, BUT THE CONTENTS DO NOT MATCH THE ORDERED PRODUCT, RESULTING IN THE CORRECT BOXES CONTAINING THE WRONG ITEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121225 ↗
• MalfunctionSep 23, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121206 ↗
• MalfunctionSep 23, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED TO THE SALES REP THAT ON 9/19/2025 THE CUSTOMER RECEIVED FOUR BOXES, EACH WITH THE CORRECT PRODUCT CODE LABEL. HOWEVER, THE ITEMS INSIDE THE BOXES WERE INCORRECT. THE CUSTOMER ORDERED PRODUCT CODE FOR THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR, BUT THE ACTUAL ITEMS RECEIVED WERE LAPAROSCOPIC DUAL RIGID APPLICATOR. THE BOXES THEMSELVES ARE CORRECTLY LABELED, BUT THE CONTENTS DO NOT MATCH THE ORDERED PRODUCT, RESULTING IN THE CORRECT BOXES CONTAINING THE WRONG ITEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121162 ↗
• MalfunctionSep 10, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER ORDERED THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR, BUT WHEN PRODUCT BOX WAS OPENED, THE WRONG PRODUCT A LAPAROSCOPIC DUAL RIGID APPLICATOR WAS INSIDE THE PRODUCT BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019936 ↗
• MalfunctionAug 25, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE ACCOUNT RECEIVED AN INCORRECT PRODUCT. OUTSIDE THE SHIPPING LABEL PRODUCT CODE IS FOR THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 45CM, BUT THE ACTUAL PRODUCT THEY RECEIVED IS LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 35CM. ADDITIONAL INFORMATION WAS REQUESTED. NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882693 ↗
• MalfunctionAug 25, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE ACCOUNT RECEIVED AN INCORRECT PRODUCT. OUTSIDE THE SHIPPING LABEL PRODUCT CODE IS FOR THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 45CM, BUT THE ACTUAL PRODUCT THEY RECEIVED IS LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 35CM. ADDITIONAL INFORMATION WAS REQUESTED. NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882684 ↗
• MalfunctionAug 25, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE ACCOUNT RECEIVED AN INCORRECT PRODUCT. OUTSIDE THE SHIPPING LABEL PRODUCT CODE IS FOR THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 45CM, BUT THE ACTUAL PRODUCT THEY RECEIVED IS LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 35CM. ADDITIONAL INFORMATION WAS REQUESTED. NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882601 ↗
• MalfunctionAug 25, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE ACCOUNT RECEIVED AN INCORRECT PRODUCT. OUTSIDE THE SHIPPING LABEL PRODUCT CODE IS FOR THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 45CM, BUT THE ACTUAL PRODUCT THEY RECEIVED IS LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR 35CM. ADDITIONAL INFORMATION WAS REQUESTED. NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882599 ↗
• MalfunctionJul 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND FIBRIN SEALANT PREPARATION DEVICE WAS USED. WHEN THEY OPENED THE BOX THAT CAME WITH THE FIBRIN SEALANT DEVICE OUTSIDE THE SHIPPING LABEL, THE ACTUAL DEVICE RECEIVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436540 ↗
• MalfunctionApr 22, 2025Failure to Disconnect; Device Stenosis; Failure to Disconnect; Device Stenosis

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE, ONCE THE APPLICATOR WAS ATTACHED, THE PRODUCT WOULD NOT DISPENSE. THE APPLICATOR WAS ATTEMPTED TO BE REMOVED, BUT IT WOULD NOT COME OFF. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885575 ↗
• MalfunctionMar 26, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC EXTENDED RIGHT COLECTOMY PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE LUER LOCKS ARE NOT WORKING APPROPRIATELY. YOU CAN ATTACH THE DEVICE, BUT YOU CANNOT DETACH THE DEVICE. CASE CONVERTED TO AN OPEN CASE. DEVICE WAS USED WITH THE LONG TIP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700948 ↗
• MalfunctionMar 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND FIBRIN SEALANT PREPARATION DEVICE WAS USED. THERE WAS A HAIR IN THE PACKAGED WITH THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548295 ↗
• MalfunctionMay 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2021 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED AFTER TUMOR REMOVAL DURING DEFECT CLOSURE. THE WHITE SPRAY TIP WAS REMOVED PRIOR TO USE SO THE PRODUCT COULD BE DRIPPED IN MULTIPLE LOCATIONS. AFTER BEING MOVED TO USE THE LAST AMOUNT OF PRODUCT ON THE HILUM OF THE KIDNEY, IT WAS NOTICED THAT THE ORANGE RUBBER O-RING HAD BROKEN OFF. IT WAS QUICKLY GRABBED AND REMOVED ALONG WITH THE EMPTY DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THREE-MINUTE DELAY. THE BROKEN O-RING WAS REMOVED SUCCESSFULLY WITHOUT THE NEED OF ADDITIONAL INTERVENTION. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809323 ↗
• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE SCRUB TECH ATTEMPTED TO ASSEMBLE THE FIBRIN SEALANT PREPARATION DEVICE AND COULD NOT ATTACH IT. THE SURGEON ATTEMPTED TO ATTACH IT AND BROKE THE FIBRIN SEALANT PREPARATION DEVICE. THE SURGERY WAS DELAYED BY 10 MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276861 ↗
• MalfunctionJun 3, 2020Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2020 AND FIBRIN SEALANT DUAL APPLICATOR WAS USED. THERE IS TOO MUCH MEMORY AT THE DISTAL TIP OF THE APPLICATOR AND IT'S DIFFICULT TO VISUALIZE AND GRASP LAPAROSCOPICALLY. CASE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10113777 ↗