Coated VICRYL J773DRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031042896), received between Aug 21, 2023 and May 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PACEMAKER SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING SURGERY, THE NEEDLE BROKE IN HALF. ALL PIECES OF THE NEEDLES WERE ABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED AND NO HARM WAS DONE TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19280810 ↗MalfunctionAug 21, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING A COLECTOMY, THE NEEDLE WAS BROKEN AT THE MIDDLE PART DURING WOUND CLOSURE OF TUMOR RESECTION. THE NEEDLE WAS BROKEN AND THE NEEDLE ON THE SIDE WITH THE SUTURE REMAINED IN THE ABDOMINAL WALL FOR A MOMENT. ALTHOUGH THE BROKEN NEEDLE WAS COLLECTED FROM THE PATIENT¿S BODY, THE SURGEON WAS NOT SO SURE IF THE SURGEON REMOVED ALL THE BROKEN NEEDLES. THE SUTURE METHOD WAS INTERRUPTED SUTURE. THE PRODUCT WAS USED ON DERMIS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PATIENT IS IN THE HOSPITAL, AND IS MAKING GOOD PROGRESS IN RECOVERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17587980 ↗
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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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