Coated VICRYL J743DRecalls & reported problems
Ethicon, LLC · Violet Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (350)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031042674), received between Sep 14, 2018 and Mar 1, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2024Material Separation; Material Separation
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN OTOLARYNGOLOGY PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18820214 ↗MalfunctionJan 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORAL SURGERY ON 10-JAN-2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE. NO BROKEN NEEDLE WAS LEFT IN THE PATIENT¿S BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607021 ↗MalfunctionDec 4, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18264043 ↗InjurySep 14, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE STAYED IN PATIENT¿S HEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 7876812 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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