Coated VICRYL VCP351H (UDI 10705031149861)Recalls & reported problems
Ethicon Inc. · Antibacterial Violet Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (114)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031149861), received between Oct 23, 2025 and Aug 17, 2026 — classified as 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
- Defective Component3
- Product Quality Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Break
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. While handling the suture thread, it broke off the needle. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277354 ↗MalfunctionOct 23, 2025Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE HOSPITAL REPORTS THAT THE YARN USED IN SURGERY IS THINNER THAN USUAL. IMPACTING THE RESISTANCE OF THE WIRE DURING PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366869 ↗MalfunctionOct 23, 2025Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE HOSPITAL REPORTS THAT THE YARN USED IN SURGERY IS THINNER THAN USUAL. IMPACTING THE RESISTANCE OF THE WIRE DURING PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366731 ↗MalfunctionOct 23, 2025Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE HOSPITAL REPORTS THAT THE YARN USED IN SURGERY IS THINNER THAN USUAL. IMPACTING THE RESISTANCE OF THE WIRE DURING PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366729 ↗
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
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- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- 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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