Coated VICRYL VCP441HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031053274), received between Jan 8, 2020 and Jun 11, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A PERINEAL REPAIR SURGERY ON AN UNKNOWN DATE IN (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512209 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN EPISIOTOMY REPAIR ON AN UNKNOWN DATE IN MAY 2024, AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512092 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERINEAL REPAIR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, ABOUT 1- 2 WEEKS AFTER THE SURGERY, THE PATIENT CAME TO HOSPITAL FOR EXAMINATION, AND REPORTED DISCOMFORT WITH THE WOUND. THE WOUND WAS CHECKED AND FOUND WITH POOR WOUND HEALING. THEN DEBRIDEMENT AND RESEWING WAS PERFORMED TO THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Impaired Healing

  MAUDE report 19386150 ↗
• MalfunctionApr 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST MASS EXCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, WHILE SEWING THE SKIN, THE SUTURE PULLED OFF THE NEEDLE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047405 ↗
• MalfunctionJan 8, 2020Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN EPISIOTOMY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PULLED OFF SUTURE AFTER SEWING THE FIRST STITCH. CHANGED TO ANOTHER SUTURE TO COMPLETE THE SURGERY. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9563735 ↗

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