ETHICON VSTAS1ERecalls & reported problems

Summary

The FDA's MAUDE database contains 210 adverse event reports that list this exact device (DI 10705031462533), received between Jun 17, 2020 and Sep 10, 2025 — classified as 210 malfunctions.

The most frequently reported specific device problem is “Failure to Disconnect” (142 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 25 most recent of 210 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025No Flow

  VISTASEAL FIBRIN SEALANT WAS REQUESTED FOR USE DURING SURGERY, BUT AFTER PUTTING THE KIT TOGETHER, THE SEALANT WOULDN'T DISPENSE. A NEW KIT WAS OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014879 ↗
• MalfunctionJul 31, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING GENERAL SURGERY UNDER ROBOTIC ASSISTANCE, THE STAFF COULD NOT REMOVE THE OPEN APPLICATOR TIP IN ORDER TO PUT ON THE LAPAROSCOPIC TIP. THE GREY LUER LOCK WAS STUCK. THE CASE WAS COMPLETED BY OPENING ANOTHER LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673929 ↗
• MalfunctionJul 22, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE SURGICAL TECH WAS UNABLE TO UNSCREW THE GRAY LUER LOCKS TO REMOVE THE OPEN APPLICATOR BEFORE ATTACHING THE LAPAROSCOPIC APPLICATOR. THEY HAD ALREADY USED ONE 4ML OF FIBRIN SEALANT PREPARATION DEVICE WITH A LAP APPLICATOR ON THE CASE SO THE SURGEON DETERMINED THEY WEREN¿T GOING TO USE THE SECOND 4ML OF FIBRIN SEALANT PREPARATION DEVICE AFTER HAVING TROUBLE DISCONNECTING THE OPEN APPLICATOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563982 ↗
• MalfunctionJul 8, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE SURGERY THE CAP WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439204 ↗
• MalfunctionJun 25, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE OPEN APPLICATOR TIP WAS UNABLE TO DETACH, PREVENTING THE APPLICATION OF THE LAPAROSCOPIC TIP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331065 ↗
• MalfunctionJun 17, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARTMAN'S PROCEDURE COLOSTOMY REVERSAL PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. ON THE TABLE THE LEUER LOCKS WERE STUCK. THEY WERE LIKE FUSED. UNABLE TO REMOVE TO APPLY THE LAPAROSCOPIC TIP. CASE WAS COMPLETED WITH A LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22242863 ↗
• MalfunctionJun 12, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE EXPIRATION ON THE BOX IS DIFFERENT FROM THE EXPIRATION ON THE PRODUCT INSIDE THE BOX. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197895 ↗
• MalfunctionJun 12, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE DEVICE DID NOT MEET CUSTOMER EXPECTATIONS. CASE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197004 ↗
• MalfunctionMay 28, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING SURGERY, WHILE USING THE FIBRIN SEALANT PREPARATION DEVICE, THE SCRUB TECH HAD THAWED OUT THE BIOLOGIC. THE LEUR LOCKS COMPLETELY LOCKED AND WOULD NOT BUDGE. THE OPEN TIP WILL NOT BUDGE, AND THEY CAN'T GET THE TIP ON. CASE WAS COMPLETED WITH A LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100647 ↗
• MalfunctionMay 28, 2025Failure 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 AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE, THE FACILITY COULDN'T GET THE WHITE TIP OFF TO PUT ON THE LAPAROSCOPIC. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099889 ↗
• MalfunctionMay 19, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GENERAL PROCEDURE ON AN UNKNOWN DATE. THE CUSTOMER RECEIVED DAMAGED PACKAGING AND DEFECTIVE FIBRIN SEALANT PREPARATION DEVICE. THERE WAS NO PATIENT USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043251 ↗
• MalfunctionMay 16, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GENERAL PROCEDURE ON (B)(6) 2025 AND FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE TWO FIBRIN SEALANT PREPARATION DEVICES THE GRAY LEURS WERE COMPLETELY LOCKED. THEY COULD NOT GET THE LEURS TO MOVE. CASE WAS COMPLETED WITH LIKE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040346 ↗
• MalfunctionMay 16, 2025Failure 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 AN UNKNOWN GENERAL PROCEDURE ON (B)(6) 2025 AND FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE TWO FIBRIN SEALANT PREPARATION DEVICES THE GRAY LEURS WERE COMPLETELY LOCKED. THEY COULD NOT GET THE LEURS TO MOVE. CASE WAS COMPLETED WITH LIKE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040226 ↗
• MalfunctionMay 14, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE THEY COULD NOT GET THE GRAY TIP OFF THE FIBRIN SEALANT PREPARATION DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023076 ↗
• 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 21885547 ↗
• MalfunctionApr 22, 2025Material 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 APPLICATOR BROKE WHILE TRYING TO SWITCH TO LAP APPLICATOR. WAS UNABLE TO USE FIBRIN SEALANT PREPARATION DEVICE BECAUSE OF BROKEN PIECES. THE PROCEDURE WAS DELAYED BY FIVE MINUTES.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884969 ↗
• 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 21701092 ↗
• MalfunctionMar 4, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE, THEY WERE TRYING TO DISCONNECT THE OPEN SPRAY TIP ON THE FIBRIN SEALANT PREPARATION DEVICE AND THE LEUR LOCKS LOCKED UP ON THEM. THEY HAD TO EVENTUALLY USE A CLAMP TO OPEN THE LEUR LOCK, WHICH WAS NEEDED TO ADDRESS ATTACHING THE LAPAROSCOPIC TIP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515467 ↗
• MalfunctionMar 3, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE, THEY WERE UNABLE TO REMOVE THE GRAY CAPS OFF THE SYRINGE. CASE WAS COMPLETED WITH A LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510059 ↗
• MalfunctionMar 3, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DURING THE PROCEDURE, THEY WERE UNABLE TO REMOVE THE GRAY CAPS OFF THE SYRINGE. CASE WAS COMPLETED WITH A LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509970 ↗
• MalfunctionMar 3, 2025Material 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. SOMETIME LAST YEAR DURING AN UNKNOWN PROCEDURE THE DEVICE IS BROKEN. 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 21506800 ↗
• MalfunctionMar 3, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT TOTAL KNEE ARTHOSCOPY (TKA) PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE TIP WOULD NOT SNAP ON CORRECTLY. ANOTHER DEVICE WAS OPENED. TWO WERE OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503435 ↗
• MalfunctionJan 22, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE THE OPEN TIP WOULD NOT COME OFF. CASE WAS COMPLETED WITH A LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211633 ↗
• MalfunctionDec 10, 2024Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON (B)(6) 2024 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE STAFF WAS UNABLE TO BE ABLE TO OPEN THE LURE LOCKS TO REMOVE THE TIP. 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 20891488 ↗
• MalfunctionDec 3, 2024Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE OPEN SPRAY TIP WOULD NOT COME OFF AS IT APPEARED TO BE STUCK. THEY ATTEMPTED TO TROUBLESHOOT WITH IT, BUT AFTER THE ATTEMPT FAILED THEY GOT A NEW ONE TO PROCEED WITH THE CASE WITHOUT ANY MORE ISSUES NOR PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832726 ↗