Coated VICRYL J418HRecalls & reported problems
Johnson & Johnson International Inc. · Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (50)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031039704), received between Apr 6, 2022 and Jul 19, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information4
- Local Reaction1
- Purulent Discharge1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THEY BROUGHT THE PATIENT BACK ON (B)(6) 2024, AND NOTICED THERE WERE SIGNS OF INFECTION, AND THE INCISION WAS FALLING APART. THEY SENT THE DEVICE TO THEIR LAB TO HAVE CULTURES TAKEN ON IT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Local Reaction; Purulent Discharge; Unspecified Infection; Wound Dehiscence
MAUDE report 19780131 ↗MalfunctionApr 6, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE STARTED TO COME UNDONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14033350 ↗MalfunctionApr 6, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE STARTED TO COME UNDONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14033289 ↗MalfunctionApr 6, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE STARTED TO COME UNDONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14033114 ↗MalfunctionApr 6, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE STARTED TO COME UNDONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14032975 ↗
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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
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
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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