Coated VICRYL VCP977HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031056251), received between Nov 14, 2019 and Dec 15, 2025 — classified as 1 injury, 3 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 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.

• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A GENERAL PROCEDURE, THE NEEDLE POPPED OFF TWICE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802242 ↗
• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A GENERAL PROCEDURE, THE NEEDLE POPPED OFF TWICE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802241 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING A C-SECTION IT WAS NOTED BY THE SCRUB TECH PRIOR TO USE ON THE PATIENT THAT THE TIP OF THE NEEDLE LOOKED/FELT WRONG AND WAS POSSIBLY BROKEN OFF. AN X-RAY WAS DONE JUST TO BE SURE THERE WERE NO FRAGMENTS IN THE PATIENT AND NONE WERE FOUND. ANOTHER SUTURE STRAND WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598761 ↗
• InjuryNov 14, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE NEEDLE TIP BROKE OFF DURING THE PROCEDURE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THE PATIENT UNDERWENT AN UNKNOWN SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE OBTAINED.

  Patient problems: Not Applicable

  MAUDE report 9323895 ↗

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