Coated VICRYL J516HRecalls & reported problems
Ethicon Inc. · Violet Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031040830), received between Jun 10, 2020 and May 20, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Defective Component” (6 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
- Defective Component6
- Break3
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2025Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THIS 3-0 SUTURE HAS BECOME THINNER. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053055 ↗MalfunctionMay 20, 2025Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THIS 3-0 SUTURE HAS BECOME THINNER. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053052 ↗MalfunctionMay 20, 2025Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THIS 3-0 SUTURE HAS BECOME THINNER. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053040 ↗MalfunctionMay 20, 2025Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THIS 3-0 SUTURE HAS BECOME THINNER. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053039 ↗MalfunctionMay 20, 2025Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THIS 3-0 SUTURE HAS BECOME THINNER. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053023 ↗MalfunctionMay 20, 2025Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THIS 3-0 SUTURE HAS BECOME THINNER. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052929 ↗MalfunctionMar 11, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE NEEDLE AND THREAD SEPARATED IN THE PROCESS. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874203 ↗MalfunctionNov 1, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHEN SUTURING PERITONEAL ADIPOSE TISSUE, THREAD IS BROKEN DURING KNOTTING, AND THE BROKEN PART IS THE SUTURE BODY. THE NEEDLE DOES NOT FALL INTO THE PATIENT'S BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15712102 ↗MalfunctionNov 1, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, WHEN SUTURING PERITONEAL ADIPOSE TISSUE, THREAD IS BROKEN DURING KNOTTING, AND THE BROKEN PART IS THE SUTURE BODY. THE NEEDLE DOES NOT FALL INTO THE PATIENT'S BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15712098 ↗MalfunctionJun 10, 2020Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THIS SUTURE WAS VERY EASY TO BREAK. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10136571 ↗
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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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