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Coated VICRYL J350HRecalls & reported problems

Ethicon, LLC · Violet Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant

All models of Coated VICRYL (350)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 17891338030414), received between Dec 16, 2020 and Jun 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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

Device problems

  • Break1
  • Component Misassembled1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 21, 2022Component Misassembled; Component Misassembled

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS NOTED THAT THE SUTURE WAS SHORT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14763857 ↗
  • MalfunctionDec 16, 2020Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN GYNECOLOGICAL PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11016007 ↗

Recalls under the same FDA submission

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

  • 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

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page