Coated VICRYL J460HRecalls & reported problems
Johnson & Johnson International Inc. · Violet Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (50)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031040090), received between Aug 27, 2024 and Feb 4, 2025 — classified as 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE USER WAS HAVING PROBLEMS WITH A BATH OF SUTURES. DISINTEGRATION OF THE THREAD AT THE TIME OF SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303234 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE USER WAS HAVING PROBLEMS WITH A BATH OF SUTURES. DISINTEGRATION OF THE THREAD AT THE TIME OF SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303132 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THE NEEDLE WAS BROKEN IN USE. THE CONTINUOUS SUTURING WAS PERFORMED. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WAS NO SURGICAL DELAY. THE BROKEN NEEDLE WAS DISCARDED BECAUSE THE NEEDLE WAS BADLY STAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20076258 ↗
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- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
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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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