ETHICON VSTL35Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031462571), received between Mar 11, 2020 and Aug 27, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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.

• MalfunctionAug 27, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE CUSTOMER ORDERED 2 BOXES OF THE VISTASEAL LAPAROSCOPIC FLEXIBLE APPLICATOR BUT THEY RECEIVED THE VISTASEAL LAPAROSCOPIC FLEXIBLE APPLICATOR INSTEAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22908870 ↗
• MalfunctionAug 27, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE CUSTOMER ORDERED 2 BOXES OF THE VISTASEAL LAPAROSCOPIC FLEXIBLE APPLICATOR BUT THEY RECEIVED THE VISTASEAL LAPAROSCOPIC FLEXIBLE APPLICATOR INSTEAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22908718 ↗
• MalfunctionAug 26, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CUSTOMER HAVE REPORTED RECEIVING A LAPAROSCOPIC DUAL RIGID APPLICATOR WHEN THEY INTENDED TO PURCHASE THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR. THE LOT NUMBER REPORTED BELONGS TO THE LAPAROSCOPIC DUAL FLEXIBLE APPLICATOR NOT THE LAPAROSCOPIC DUAL RIGID APPLICATOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900362 ↗
• MalfunctionAug 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ITEM VSTL35 THAT REFERENCES LOT 5866415. ACCORDING TO THE SYSTEM, THIS LOT IS ONLY ASSOCIATED WITH ITEM VSTL45. THIS IS A PRODUCT COMPLAINT DUE TO LABELING ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843535 ↗
• MalfunctionAug 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE CUSTOMERS HAVE REPORTED RECEIVING PRODUCT CODE VSTL35 WITH LOT NUMBER 5866415 WHEN THEY INTENDED TO PURCHASE PRODUCT CODE VSTL45. LOT NUMBER 5866415 BELONGS TO VSTL45 NOT VSTL35. THE LABELING FOR PRODUCT CODE VSTL35 NEEDS REVIEWING TO ENSURE THAT IT'S LABELED WITH THE CORRESPONDING LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843259 ↗
• MalfunctionApr 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE SURGEON CONCERNED THAT THE MECHANISM THAT ATTACHES TO THE SYRINGE IS VERY PRONE FOR MISALIGNMENT NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179768 ↗
• MalfunctionFeb 6, 2024Failure to Disconnect; Appropriate Device Problem Term/Code Not Available; Failure to Disconnect; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE ON (B)(6) 2023 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE TECH HAD DIFFICULTY CONNECTING APPLICATOR TO PRE-FILLED SYRINGE. THEY GOT ANOTHER APPLICATOR TO PROCEED WITH THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651587 ↗
• MalfunctionNov 29, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE APPLICATOR TIP WOULD NOT SCREW ON TO THE DEVICE, PRODUCT WOULD NOT DISPENSE. A SECOND 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 18231015 ↗
• MalfunctionOct 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE SPRAY TIPS HAVE BEEN INCONSISTENT WHERE IT SPRAYS AS A LASER/STRAIGHT LINE AND NOT THE MIST FORM IT USUALLY DOES FROM LAPAROSCOPIC TIP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997633 ↗
• MalfunctionOct 11, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE THE TIP BROKE WHILE TRYING TO ATTACH IT TO THE APPLICATOR. THEY REPLACED IT WITH ANOTHER LIKE PRODUCT. ALL OF THE PIECES WERE RETRIEVED NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575062 ↗
• MalfunctionApr 1, 2022Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2022 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE FIBRIN SEALANT PREPARATION DEVICE WOULD NOT CONNECT PROPERLY WHEN THEY WENT TO SCREW IT ON. IT TURNED BOTH WAYS, BUT IT WOULD NOT CONNECT TO THE ACTUAL BIOLOGIC. THE CASE WAS COMPLETED WITH ANOTHER TIP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981871 ↗
• MalfunctionSep 21, 2021Leak/Splash; Connection Problem; Activation Problem; Leak/Splash; Connection Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SLEEVE GASTRECTOMY ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE FIBRIN SEALANT PREPARATION DEVICE WAS SET UP ON THE BACK TABLE BY THE SCRUB TECH TO BE USED OVER THE STAPLE LINE. THE DEVICE WAS INTRODUCED THROUGH A 5MM TROCAR BY THE PA AND THE PLUNGER WAS DEPRESSED TO EXPRESS THE PRODUCT. THE PA NOTED THAT THE PLUNGER WAS DIFFICULT TO DEPRESS DURING THE EXPRESSION. THERE WAS LEAKING FROM THE CONNECTION OF THE ASSEMBLY TO THE FIBRIN SEALANT PREPARATION DEVICE. THE PURPLE PLUNGER CAP DISLODGED FROM THE PRE-FILLED SYRINGE. THE PA NOTED THAT WHILE IT APPEARED THAT THE BIOLOGICS WERE EXPRESSED, THERE DID NOT APPEAR TO BE A CLOT FORMED OVER THE STAPLE LINE. A NEW FIBRIN SEALANT PREPARATION DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. THE PROCEDURE WAS DELAYED BY TEN MINUTES. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510967 ↗
• MalfunctionFeb 12, 2021Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2020 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. WHILE ATTEMPTING TO USE THE PRODUCT, IT WOULDN¿T EXPRESS. THE USER TRIED TO CHANGE THE TIP OUT AND COULD NOT, AND IT APPEARED TO CRIMP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322518 ↗
• MalfunctionNov 26, 2020Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA PROCEDURE ON (B)(6) 2020, AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE THE LUER LOCK WOULD NOT OPEN, AND THE TIP WOULD NOT TWIST. AS A CONSEQUENCE, THE LAPAROSCOPIC APPLICATOR COULD NOT BE ATTACHED. THE SURGEON HAD TO USE A CLAMPING DEVICE TO EVENTUALLY GET THE TIP ON TO THE DEVICE, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911254 ↗
• MalfunctionOct 2, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE, THE HANDLE BROKE, AND ONLY SOME OF ONE SIDE OF THE BIOLOGIC CAME OUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10624086 ↗
• MalfunctionMar 11, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT WAS USED. PRE-OPERATIVELY, WHEN THEY OPENED THE PACKAGE A HAIR WAS PRESENT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821970 ↗