Coated VICRYL VCP581GRecalls & reported problems
Ethicon, LLC · Antibacterial 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
- 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 10705031078611), received between Apr 9, 2026 and Apr 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING AN CESARIAN SECTION CLOSURE SURGEON WAS COMPLETING THE SUB-CUTANEOUS CLOSURE WITH A RUNNING STICH, WHEN THE NEEDLE TIP BROKE OFF. STAFF REPORTS THAT THERE WAS MINIMAL DELAY IN THE CASE: "30 SECONDS TO A MINUTE". THE TIP OF THE NEEDLE WAS ABLE TO BE RETRIEVED FROM THE PATIENT. NO X-RAY WAS NEEDED TO LOCATE THE NEEDLE TIP. A NEW SUTURE WAS OBTAINED (VCP581) AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. NO HARM WAS REPORTED TO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24834497 ↗
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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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