Coated VICRYL VCP215HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031051683), received between Jun 11, 2019 and Mar 18, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, UPON VAGINAL CUFF CLOSURE, THE SUTURE BROKE AWAY FROM THE NEEDLE. WHEN APPLYING TENSION AFTER THE SURGEON TAKES A BITE, WHEN THEY GRASP THE SUTURE IS POPPING OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632649 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, UPON VAGINAL CUFF CLOSURE, THE SUTURE BROKE AWAY FROM THE NEEDLE. WHEN APPLYING TENSION AFTER THE SURGEON TAKES A BITE, WHEN THEY GRASP THE SUTURE IS POPPING OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632638 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING USE ON THE PATIENT, THE NEEDLE BROKE ON SUTURE END OF NEEDLE. THE NEEDLE WAS NOT RETAINED IN PATIENT. LOT WAS PULLED FROM USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690604 ↗
• MalfunctionDec 30, 2021Break

  NEEDLE BROKE ON SUTURE END OF NEEDLE. NEEDLE WAS NOT RETAINED IN PATIENT. LOT WAS PULLED FROM USE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13141975 ↗
• MalfunctionMay 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE AMPUTATION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN ABOVE THE KNEE AMPUTATION WHILE SUTURING SUBCUTANEOUSLY IN FASCIA THE NEEDLE POPPED OFF OF TWO SUTURES. THEY WERE RETRIEVED. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807263 ↗
• MalfunctionJun 11, 2019Material Frayed; Inadequacy of Device Shape and/or Size; Material Frayed; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE SUTURE WAS FRAYING DURING USE, AND ALMOST POPPING OFF FROM THE NEEDLE. THE SUTURE FELT THINNER THAN NORMAL AND WEAK COMPOSITION. THE SUTURE FELT AS IF IT WAS GOING TO RIP WHEN SECURING TO TIE THE KNOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689022 ↗

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