Coated VICRYL VCPB341HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031056411), received between May 21, 2019 and Jun 10, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UN KNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458681 ↗
• MalfunctionSep 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR SUTURED THE QUADRICEPS TENDON FOR THE PATIENT, BUT WHEN THE SUTURE WAS RETRACTED, THE SUTURE PULLED OFF THE NEEDLE. THE DOCTOR INSERTED THE SUTURE INTO THE HOLE AT THE END OF THE NEEDLE AND CONTINUED TO USE IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085401 ↗
• MalfunctionJul 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AFTER THE FIRST STITCH PASSED THROUGH THE TISSUE. AFTER THE FIRST STITCH AT THE END OF THE REMAINING SUTURE BECAME TANGLED, CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478532 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2023 AND SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT COMPLAINED OF INCISION PAIN WITHOUT OBVIOUS ABNORMALITIES. ONE WEEK LATER, THE PATIENT COMPLAINED OF PAIN AT THE RIGHT HIP WOUND WITH OBVIOUS FIXED TENDERNESS, LOCATED AT THE KNOT DURING THE RIGHT TOTAL HIP ARTHROPLASTY SURGERY. THE PATIENT EXPERIENCED POST-OP INFLAMMATION. THERE WAS NO SIGNIFICANT INCREASE IN BLOOD COUNT AND NO OBVIOUS ABNORMALITY WAS FOUND ON THE DR FILM. CONSIDERING THE SUTURE REJECTION REACTION, THE PATIENT'S PAIN SYMPTOMS WERE SIGNIFICANTLY RELIEVED AFTER ANTI-INFLAMMATORY TREATMENT WITH DEXAMETHASONE, AND RESIDUAL PAIN REMAINED AFTER DISCHARGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Local Reaction; Pain

  MAUDE report 17904521 ↗
• MalfunctionSep 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON NEEDED TO USE SUTURE TO SUTURE THE SKIN, THE SURGEON FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE PROCEDURE WAS SMOOTH, AND THE PATIENT RETURNED TO THE WARD SAFELY AFTER THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711934 ↗
• MalfunctionNov 11, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304453 ↗
• MalfunctionMay 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING SEWING UTERUS THE NEEDLE PULLED OFF THE SUTURE. THE NEEDLE WAS RETRIEVED FROM THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8630384 ↗

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