Coated VICRYL VCP494HRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031053700), received between Jul 24, 2023 and Jan 27, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST MASS EXCISION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246197 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE OFF. THE SURGEON HAD NOT GRASPED THE TIP OF THE NEEDLE. FRAGMENTS WERE GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19970997 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE OFF. THE SURGEON HAD NOT GRASPED THE TIP OF THE NEEDLE. FRAGMENTS WERE GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19970994 ↗
• MalfunctionFeb 14, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE WAS TOO DULL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703246 ↗
• InjuryJul 24, 2023Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE CAUSING A DEHISCENCE ON THE PATIENT (FACE, LIPS, MOUTH). THE SURGERY WAS DELAYED BY 30 MINUTES. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, ¿THE PATIENT HAD TO HAVE SURGERY AGAIN¿. THIS EVENT WAS REPORTED TO HAVE OCCURRED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17385146 ↗
• InjuryJul 24, 2023Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE CAUSING A DEHISCENCE ON THE PATIENT (FACE, LIPS, MOUTH). THE SURGERY WAS DELAYED BY 30 MINUTES. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, ¿THE PATIENT HAD TO HAVE SURGERY AGAIN¿. THIS EVENT WAS REPORTED TO HAVE OCCURRED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17385139 ↗
• InjuryJul 24, 2023Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE CAUSING A DEHISCENCE ON THE PATIENT (FACE, LIPS, MOUTH). THE SURGERY WAS DELAYED BY 30 MINUTES. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, ¿THE PATIENT HAD TO HAVE SURGERY AGAIN¿. THIS EVENT WAS REPORTED TO HAVE OCCURRED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17385117 ↗
• InjuryJul 24, 2023Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE CAUSING A DEHISCENCE ON THE PATIENT (FACE, LIPS, MOUTH). THE SURGERY WAS DELAYED BY 30 MINUTES. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, ¿THE PATIENT HAD TO HAVE SURGERY AGAIN¿. THIS EVENT WAS REPORTED TO HAVE OCCURRED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17385087 ↗
• InjuryJul 24, 2023Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE CAUSING A DEHISCENCE ON THE PATIENT (FACE, LIPS, MOUTH). THE SURGERY WAS DELAYED BY 30 MINUTES. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, ¿THE PATIENT HAD TO HAVE SURGERY AGAIN¿. THIS EVENT WAS REPORTED TO HAVE OCCURRED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17385060 ↗
• InjuryJul 24, 2023Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE CAUSING A DEHISCENCE ON THE PATIENT (FACE, LIPS, MOUTH). THE SURGERY WAS DELAYED BY 30 MINUTES. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, ¿THE PATIENT HAD TO HAVE SURGERY AGAIN¿. THIS EVENT WAS REPORTED TO HAVE OCCURRED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17385041 ↗

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