Coated VICRYL VCP497H (UDI 10705031053823)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031053823), received between Jun 7, 2018 and Dec 12, 2024 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TLIF PROCEDURE IN 2024 AND SUTURE WAS USED. A NEEDLE TIP BROKE OFF OF THE NEEDLE. PROCEDURE WAS STOPPED AND X RAY WAS DONE TO FIND NEEDLE TIP. NEEDLE TIP WAS RECOVERED BUT NOT SAVED PER THE CUSTOMER. THERE WAS NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF FIVE TO TEN MINUTES. DEVICE WAS NOT RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918240 ↗
• 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 17385138 ↗
• 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 17385075 ↗
• 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 17385073 ↗
• 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 17385053 ↗
• 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 17385044 ↗
• 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 17385035 ↗
• MalfunctionDec 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGEON WAS HAVING ISSUES WITH SUTURE BREAKING AT THE SWAGE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457512 ↗
• MalfunctionDec 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGEON WAS HAVING ISSUES WITH SUTURE BREAKING AT THE SWAGE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457498 ↗
• MalfunctionDec 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGEON WAS HAVING ISSUES WITH SUTURE BREAKING AT THE SWAGE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457494 ↗
• InjuryJun 7, 2018Extrusion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED TO SEW THE SUBCUTANEOUS TISSUE. FOLLOWING THE PROCEDURE, THE SUTURE THREAD CAME OUT FROM THE SKIN. THE PATIENT MAY HAVE GONE TO THE HOSPITAL TO CUT SUTURE THROUGH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7580738 ↗

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