Coated VICRYL J824GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031043138), received between Jul 27, 2018 and Jul 30, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K022269, K183183); 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.

• InjuryJul 30, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT WAS READMITTED DUE TO THE SUTURE BREAKING POST PROCEDURE. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 7731581 ↗
• InjuryJul 27, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT WAS READMITTED DUE TO THE SUTURE BREAKING POST PROCEDURE. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 7728735 ↗
• InjuryJul 27, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT WAS READMITTED DUE TO THE SUTURE BREAKING POST PROCEDURE. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 7728719 ↗
• InjuryJul 27, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT WAS READMITTED DUE TO THE SUTURE BREAKING POST PROCEDURE. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 7728706 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc