Coated VICRYL VCP103GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031051379), received between Jun 3, 2021 and Dec 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THIS IS A COMPLAINT ABOUT THE VCP103G PACKAGE. THE SPONGE WHICH IS ORIGINALLY ATTACHED ONLY INSIDE THAT PROTECTS THE SUTURE HAS PROTRUDED TO THE OUTSIDE (SURFACE) OF THE PACKAGE, SO THAT PIECES OF THE SPONGE FALL OFF ONTO THE SURGICAL FIELD EACH TIME THE SUTURE IS TAKEN OUT. IT OCCURRED IN THE SURGERY WHEN USING THE PRODUCT. UNTIL NOW, THE SPONGE HAD NEVER PROTRUDED TO THE OUTSIDE OF THE PACKAGE. THERE IS NO EFFECT ON THE PATIENT. THE 2ND LOT NUMBER IS UCMECU. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891655 ↗
• MalfunctionDec 10, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THIS IS A COMPLAINT ABOUT THE VCP103G PACKAGE. THE SPONGE WHICH IS ORIGINALLY ATTACHED ONLY INSIDE THAT PROTECTS THE SUTURE HAS PROTRUDED TO THE OUTSIDE (SURFACE) OF THE PACKAGE, SO THAT PIECES OF THE SPONGE FALL OFF ONTO THE SURGICAL FIELD EACH TIME THE SUTURE IS TAKEN OUT. IT OCCURRED IN THE SURGERY WHEN USING THE PRODUCT. UNTIL NOW, THE SPONGE HAD NEVER PROTRUDED TO THE OUTSIDE OF THE PACKAGE. THERE IS NO EFFECT ON THE PATIENT. THE 2ND LOT NUMBER IS UCMECU. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891641 ↗
• MalfunctionJun 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE LENGTH OF THE SUTURE WAS SHORT BY 10 CM WHEN COMPARED TO A LIKE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930401 ↗

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