Coated VICRYL VCP494GRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031053694), received between Mar 28, 2019 and Sep 30, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Material Separation” (20 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The suture was broken during use. It was not a control release needle. Another product was used to complete the case. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946248 ↗
• MalfunctionAug 17, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50285046 ↗
• MalfunctionAug 17, 2026Material Separation

  It was reported that a patient underwent a cholecystectomy procedure on (b)(6)2026 and barbed suture was used. During a cholecystectomy procedure performed in early (b)(6)2026, the surgeon reported that the suture experienced needle detachment from the suture thread during use. The issue occurred more than once, raising concerns about the needle-to-suture attachment. The surgeon commented that older batches of the suture felt stronger and did not have this needle detachment issue, whereas the current batch appeared to detach more easily. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274914 ↗
• MalfunctionAug 17, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274911 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE DETACH FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842889 ↗
• MalfunctionOct 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE STRAIGHT AWAY DISENGAGED FROM THE NEEDLE DURING THE FIRST STITCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415540 ↗
• MalfunctionOct 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE STRAIGHT AWAY DISENGAGED FROM THE NEEDLE DURING THE FIRST STITCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415535 ↗
• MalfunctionSep 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER ACCOUNT THAT: " WE HAVE BEEN GETTING THE ETHICON 4-0 VICRYL PLUS SUTURES AND THIS LAST BOX WE HAVE HAD 3 OCCASIONS NOW WHERE THE THREAD HAS BROKE OFF THE NEEDLE WHILE SUTURING. THIS HAS NEVER BEEN AN ISSUE IN THE PAST BUT NOW ALL THE SUDDEN SEEMS TO BE HAPPENING VERY FREQUENTLY. I'M UNSURE IF THEY'VE MADE SOME CHANGES TO IT RECENTLY OR IF WE JUST RECEIVED A FAULTY BATCH. " NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085293 ↗
• MalfunctionSep 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER ACCOUNT THAT: " WE HAVE BEEN GETTING THE ETHICON 4-0 VICRYL PLUS SUTURES AND THIS LAST BOX WE HAVE HAD 3 OCCASIONS NOW WHERE THE THREAD HAS BROKE OFF THE NEEDLE WHILE SUTURING. THIS HAS NEVER BEEN AN ISSUE IN THE PAST BUT NOW ALL THE SUDDEN SEEMS TO BE HAPPENING VERY FREQUENTLY. I'M UNSURE IF THEY'VE MADE SOME CHANGES TO IT RECENTLY OR IF WE JUST RECEIVED A FAULTY BATCH. " NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085286 ↗
• MalfunctionSep 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER ACCOUNT THAT: " WE HAVE BEEN GETTING THE ETHICON 4-0 VICRYL PLUS SUTURES AND THIS LAST BOX WE HAVE HAD 3 OCCASIONS NOW WHERE THE THREAD HAS BROKE OFF THE NEEDLE WHILE SUTURING. THIS HAS NEVER BEEN AN ISSUE IN THE PAST BUT NOW ALL THE SUDDEN SEEMS TO BE HAPPENING VERY FREQUENTLY. I'M UNSURE IF THEY'VE MADE SOME CHANGES TO IT RECENTLY OR IF WE JUST RECEIVED A FAULTY BATCH. " NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085281 ↗
• MalfunctionMay 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968736 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945830 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945821 ↗
• MalfunctionNov 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE FELL OF FROM NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093500 ↗
• MalfunctionNov 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BROKE OFF AT NEEDLE SWAGE AFTER SURGEON TAKING 2 BITES. SURGEON MENTIONED THAT SHE DID NOT PULL VERY HARD DURING THE 2 BITES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074081 ↗
• MalfunctionNov 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BROKE OFF AT NEEDLE SWAGE AFTER SURGEON TAKING 2 BITES. SURGEON MENTIONED THAT SHE DID NOT PULL VERY HARD DURING THE 2 BITES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074028 ↗
• MalfunctionSep 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN USING NEEDLE HOLDER HOLD THE NEEDLE, THE NEEDLE SEPARATED FROM THE SUTURE. CHANGED A NEW ONE AND SAFELY COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741675 ↗
• MalfunctionJun 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED 6 TIMES CONSECUTIVELY, TOTAL OF 6 PCS OF SUTURES WERE OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189637 ↗
• MalfunctionJun 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED 6 TIMES CONSECUTIVELY, TOTAL OF 6 PCS OF SUTURES WERE OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189627 ↗
• MalfunctionJun 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED 6 TIMES CONSECUTIVELY, TOTAL OF 6 PCS OF SUTURES WERE OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189626 ↗
• MalfunctionJun 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED 6 TIMES CONSECUTIVELY, TOTAL OF 6 PCS OF SUTURES WERE OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189624 ↗
• MalfunctionJun 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED 6 TIMES CONSECUTIVELY, TOTAL OF 6 PCS OF SUTURES WERE OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189620 ↗
• MalfunctionJun 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED 6 TIMES CONSECUTIVELY, TOTAL OF 6 PCS OF SUTURES WERE OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189618 ↗
• MalfunctionApr 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE DURING CONTINUOUS SUTURING WHILE PASSING THE NEEDLE THROUGH THE DERMIS. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11709242 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURES OPENED IN LESS THAN THREE DAYS LEAVING THE IMPLANT EXPOSED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 11262658 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and