Coated VICRYL VCP517HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031054028), received between Apr 8, 2020 and Jun 22, 2026 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE WAS BREAKING IN THE PACKAGE. BY THE SUTURE WAS CRACK LIKE A SOLID MATERIAL IN SEVERAL PARTS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580209 ↗
• MalfunctionJan 11, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN CYST REMOVAL ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE KNOTTING. 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 13226574 ↗
• InjurySep 23, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION ON (B)(6) AND THE SUTURE WAS USED ON THE ADIPOSE LAYER. DURING THE SURGERY, THE NEEDLE WAS BROKEN IN HALF AND BECAME EMBEDDED. X-RAY DETECTED A NEEDLE PIECE. IN ORDER TO FIND THIS MISSING PART OF THE NEEDLE, A SURGEON HAD TO CUT INTO THE LAYER OF SAME FATTY TISSUE. IT WAS REPORTED THAT EVENTUALLY, THE NEEDLE HAD BEEN FOUND DURING SAME PROCEDURE AND DISCARDED. NO NEEDLE LEFT INSIDE OF THE PATIENT. POST-OPERATIVE CARE WAS NOT CHANGED IN ANY WAY AS A RESULT OF THE EVENT. THE PATIENT WAS RE-ASSURED THAT NO NEEDLE LEFT INSIDE OF HER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522507 ↗
• MalfunctionApr 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION UNDER EPIDURAL ANESTHESIA ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN IT WAS SEWING THE UTERUS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938163 ↗

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