Coated VICRYL VCP310H (UDI 10705031149755)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031149755), received between Apr 24, 2025 and Jun 11, 2026 — classified as 1 injury, 7 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING, THE NEEDLE AND SUTURE WAS DETACHED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477513 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953297 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 A SUTURE WAS USED. THE NEEDLE TIP BROKE WHEN SEWING IN SURGERY. . CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651087 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 A SUTURE WAS USED. THE NEEDLE TIP BROKE WHEN SEWING IN SURGERY. . CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650638 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE PATIENT'S WOUND, THE SUTURE BROKE FROM THE ROOT OF THE NEEDLE. THE BROKEN END SUTURE WAS REMOVED, AND ANOTHER SUTURE WAS REPLACED AND USED NORMALLY. EXTENDED THE PATIENT'S SURGICAL TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782985 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT THE SURGERY DUE TO SCAR UTERUS. DURING THE SURGERY, THE DOCTOR USED SUTURE FOR INTRADERMAL COSMETIC SUTURING. TWO MONTHS AFTER DELIVERY, THE PATIENT'S WOUND DEVELOPED A KNOT REACTION, CAUSING LOCAL PAIN, AND FOREIGN OBJECTS AND PUS WERE SQUEEZED OUT AFTER BULGING. THE PATIENT HAD POOR WOUND HEALING. THE AREA WAS CLEANED UP AND THE DRESSING WAS CHANGED. ADDITIONAL INFORMATION WAS REQUESTED. CLEAN UP AND CHANGE THE DRESSING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Local Reaction; Pain; Purulent Discharge

  MAUDE report 23416177 ↗
• MalfunctionSep 11, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. LABEL ISSUE. BOTH VCP345H AND VCP310H PRODUCT LABEL WAS PLACED ON THE BOX. BUT INSIDE THE BOX, THE POUCH LABEL CODE IS VCP310H. THERE'S NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025497 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE TIP HAD BROKEN AS ATTACHED DURING SEWING. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899308 ↗