Coated VICRYL VCP359H (UDI 10705031077881)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031077881), received between Mar 31, 2025 and Jul 6, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE SURGEON USED SUTURE TO SEW. THE SUTURE BROKE WHEN KNOTTING, IT WAS IMMEDIATELY REPLACED AGAIN. SUTURE AGAIN, THE SURGERY WENT SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25723452 ↗
• MalfunctionJun 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION SURGERY ON (B)(6) 2026, AND SUTURE WAS USED. THE MOTHER UNDERWENT SURGERY FOR "OLIGOHYDRAMNIOS". DURING THE SURGERY, THE DOCTOR USED SUTURE TO SUTURE THE PATIENT'S INCISION. DURING THE SUTURE PROCESS, THE SUTURE BROKE AT THE ROOT, AND THE DOCTOR REPLACED THE SUTURE TO CONTINUE SUTURING THE PATIENT'S WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25654155 ↗
• MalfunctionMay 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 8:30 AM, DURING THE SURGICAL SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED NORMALLY. THE DEFECTIVE SUTURE WAS DISCARDED AND REPLACED WITH A NEW SUTURE FOR THE PATIENT TO SUTURE, WHICH DELAYED THE PATIENT'S SURGICAL PROGRESS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321467 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. 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 25072895 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. 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 25072326 ↗
• MalfunctionApr 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCESS OF SUTURING THE UTERUS WITH SUTURE, THE NEEDLE PULL OFF ISSUE HAPPENED AND IT WAS USED AGAIN AFTER THE NEEDLE WAS RE-INSERTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045773 ↗
• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. 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 24981703 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT 2 NEEDLES BROKEN DURING 1 SURGERY. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831021 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT 2 NEEDLES BROKEN DURING 1 SURGERY. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831013 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2026 AND SUTURE WAS USED. AS PART OF A CAESAREAN SECTION, DURING THE CLOSURE PHASE DURING THE SUTURE OF THE ABDOMINAL FASCIA, THE TIP OF THE NEEDLE OF OUR SUTURE BROKE. THE TIP WAS THEN, AFTER A CAREFUL SEARCH, FOUND AND REMOVED FROM THE PATIENT. THE SUTURE THREAD IN QUESTION (WITH ATTACHED NEEDLE) AND THE ENTIRE PACKAGE OF THE SAME BATCH WERE SENT TO THE HOSPITAL PHARMACY TO OPEN A REPORT TO THE MINISTRY. A SIGNIFICANT DELAY WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675079 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED AN INCIDENT OF BROKEN NEEDLE TIP. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180102 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS EASILY BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908253 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, WHEN USING SUTURE TO SUTURE THE UTERINE MUSCLE LAYER, THE SUTURE BROKE AFTER BEING PULLED AND PULLED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790649 ↗
• MalfunctionSep 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS DAMAGED/REQUIRES REPAIR OR REPLACEMENT. DURING ROUTINE USE, THREAD SEPARATED FORM NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23041148 ↗
• MalfunctionMar 31, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT GAVE BIRTH TO A LIVE BABY BOY AT 14:25. THE SURGEON DELIVERED THE PLACENTA, CLEANED THE UTERUS, AND SUTURED THE UTERUS. THE SUTURE NEEDLE BROKE WHEN THE UTERUS WAS SUTURED TO THE LAST STITCH. THE BROKEN NEEDLE WAS FOUND THROUGH X-RAY AND REMOVED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732553 ↗