Skip to content

Coated VICRYL VCP956HRecalls & reported problems

Ethicon Inc. · Antibacterial Undyed Braided (Polyglactin 910), Synthetic Absorbable Surgical Suture · Class 2 · Implant

All models of Coated VICRYL (114)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031056183), received between Apr 8, 2019 and Apr 8, 2019 — classified as 1 malfunction.

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

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 16, 2026.

Most reported problems

Device problems

  • Component Incompatible1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 8, 2019Component Incompatible; Component Incompatible

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS OPENED AND PASSED OFF TO THE FIELD AND THE ACTUAL SUTURE THAT WAS INSIDE THE PACKAGE WAS NOT THE SAME. THE FOIL WRAP SAID ONE PRODUCT CODE AND THE ACTUAL SUTURE WAS DIFFERENT. ANOTHER LIKE DEVICE WITH THE CORRECT PRODUCT CODE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8492118 ↗

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

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

All SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices →

Sources and updates

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