Coated VICRYL D7795Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031028449), received between May 29, 2025 and May 29, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Separation” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Separation4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THEY HAD AN ISSUE WITH 3-0 VICRYL EN-S. TWO REPORTED INCIDENTS OF THE NEEDLE BECOMING DETACHED FROM THE SUTURE AFTER ENTERING THE 2ND TIME THROUGH THE PORT. THE NEEDLE WAS RETRIEVED FROM THE ABDOMEN AFTER IT DETACHED. SURGICAL DELAY UNKNOWN. ONE DEVICE IS RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107059 ↗MalfunctionMay 29, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THEY HAD AN ISSUE WITH 3-0 VICRYL EN-S. TWO REPORTED INCIDENTS OF THE NEEDLE BECOMING DETACHED FROM THE SUTURE AFTER ENTERING THE 2ND TIME THROUGH THE PORT. THE NEEDLE WAS RETRIEVED FROM THE ABDOMEN AFTER IT DETACHED. SURGICAL DELAY UNKNOWN. ONE DEVICE IS RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107057 ↗MalfunctionMay 29, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THEY HAD AN ISSUE WITH 3-0 VICRYL EN-S. TWO REPORTED INCIDENTS OF THE NEEDLE BECOMING DETACHED FROM THE SUTURE AFTER ENTERING THE 2ND TIME THROUGH THE PORT. THE NEEDLE WAS RETRIEVED FROM THE ABDOMEN AFTER IT DETACHED. SURGICAL DELAY UNKNOWN. ONE DEVICE IS RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105528 ↗MalfunctionMay 29, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THEY HAD AN ISSUE WITH 3-0 VICRYL EN-S. TWO REPORTED INCIDENTS OF THE NEEDLE BECOMING DETACHED FROM THE SUTURE AFTER ENTERING THE 2ND TIME THROUGH THE PORT. THE NEEDLE WAS RETRIEVED FROM THE ABDOMEN AFTER IT DETACHED. SURGICAL DELAY UNKNOWN. ONE DEVICE IS RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105524 ↗
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, ClassifiedVICRYL (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 · TerminatedCoated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
- Z-1087-06 · May 4, 2006 · TerminatedCoated 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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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