Coated VICRYL VCP316H (UDI 10705031149786)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705031149786), received between Dec 26, 2024 and Sep 3, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589965 ↗
• MalfunctionAug 24, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50411477 ↗
• MalfunctionJul 31, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100952 ↗
• MalfunctionJul 31, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100946 ↗
• MalfunctionJul 31, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100935 ↗
• MalfunctionJul 31, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100926 ↗
• MalfunctionJul 31, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100913 ↗
• MalfunctionJul 31, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100909 ↗
• MalfunctionJul 31, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100878 ↗
• MalfunctionJun 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504789 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DOG HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT WHERE THE SUTURE BREAKS DURING SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494884 ↗
• MalfunctionDec 12, 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, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING PERITONEAL. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789915 ↗
• MalfunctionOct 29, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN SURGERY, 5 SUTURES ARE OPENED WITH A S/H NEEDLE SINCE THE NEEDLE IS CUT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417866 ↗
• MalfunctionOct 29, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN SURGERY, 5 SUTURES ARE OPENED WITH A S/H NEEDLE SINCE THE NEEDLE IS CUT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417846 ↗
• MalfunctionOct 29, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN SURGERY, 5 SUTURES ARE OPENED WITH A S/H NEEDLE SINCE THE NEEDLE IS CUT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417845 ↗
• MalfunctionOct 29, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN SURGERY, 5 SUTURES ARE OPENED WITH A S/H NEEDLE SINCE THE NEEDLE IS CUT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417844 ↗
• MalfunctionOct 29, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN SURGERY, 5 SUTURES ARE OPENED WITH A S/H NEEDLE SINCE THE NEEDLE IS CUT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417841 ↗
• MalfunctionJun 25, 2025Component Missing; Component Missing

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT WRONG AND/OR MIXED PACKAGING COMPONENTS WAS OBSERVED. IT WAS REPORTED FROM A FACILITY THAT THE EMPLOYEE FOUND EXTRA 1 EA IN THE BOX. ORIGINALLY, THERE SHOULD BE 26 EA IN THE PRODUCT BOX. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328796 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP GASTRIC BYPASS PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE STITCH, 4 SUTURES OF THE SAME TYPE ARE CUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018818 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP GASTRIC BYPASS PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE STITCH, 4 SUTURES OF THE SAME TYPE ARE CUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018817 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP GASTRIC BYPASS PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE STITCH, 4 SUTURES OF THE SAME TYPE ARE CUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018815 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP GASTRIC BYPASS PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE STITCH, 4 SUTURES OF THE SAME TYPE ARE CUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018814 ↗