Coated VICRYL VCP332HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031052376), received between Sep 5, 2019 and Jun 11, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470574 ↗
• MalfunctionDec 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING,THE NEEDLE AND SUTURE WAS DETACHED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927002 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURES BROKE EASILY DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491353 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURES BROKE EASILY DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483077 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING SKIN IN SURGERY. CHANGED TO 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 15625045 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HAND SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED TO SUTURE THE TENDON. AFTER INPATIENT FRACTURE REDUCTION AND INTERNAL FIXATION, VASCULAR, NERVE, TENDON REPAIR TREATMENT, POSTOPERATIVE SYMPTOMATIC TREATMENT WAS PROVIDED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PATIENT WAS IN A STABLE CONDITION. REGULAR OUTPATIENT FOLLOW-UP WAS PERFORMED. LATER AFTER THAT, THE PATIENT EXPERIENCED ERYTHEMA, INFLAMMATION AND PAIN ON THE WOUND ON THE BACK OF THE LEFT THUMB, AND THE OUTPATIENT DEPARTMENT WAS GIVEN SYMPTOMATIC TREATMENT SUCH AS DRESSING CHANGE. AFTER TREATMENT, THE PATIENT'S WOUNDS CONTINUED TO APPEAR REPEATEDLY ERYTHEMA, INFLAMMATION AND WOUND SECRETION. SURGICAL REMOVAL OF THE SUTURE WAS PERFORMED. DEBRIDEMENT AND CLOSURE OF THE WOUND WERE PERFORMED TOO. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Inflammation; Pain

  MAUDE report 12716601 ↗
• MalfunctionMar 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, T WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SEWING DURING THE UNKNOWN SURGERY ON (B)(6) 2021. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585498 ↗
• MalfunctionSep 10, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8982753 ↗
• MalfunctionSep 5, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE PULLED OFF THE NEEDLE WHEN SEWING DURING THE SURGERY OF LAPAROSCOPIC HIGH LIGATION OF HERNIA. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8966858 ↗

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