Coated VICRYL J499GRecalls & reported problems
Ethicon, LLC · Undyed 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
Quick summary
This Ethicon Coated VICRYL J499G absorbable surgical suture is a braided synthetic suture used to close tissue. The 39 reports all describe the same problem: the suture breaking, the braid coming undone and failing to hold tissue together, in procedures on mice. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705031040663), received between Aug 11, 2021 and Sep 8, 2021 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Break” (39 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.
Most reported problems
Device problems
- Break39
Patient problems
- No Clinical Signs, Symptoms or Conditions39
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443693 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443690 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443688 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443687 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443686 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443685 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443683 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443681 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443680 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443679 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443678 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443677 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443675 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443673 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443672 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443669 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443667 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443576 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443573 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443572 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443570 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443568 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443565 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443564 ↗MalfunctionSep 8, 2021Break; Break
IT WAS REPORTED THAT MICE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURES WILL NOT STAY TOGETHER. THE BRAID COMES UNDONE, CONSTANTLY BREAKS, AND WILL NOT HOLD TOGETHER THE INTERNAL SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443563 ↗
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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