Coated VICRYL VCP451H (UDI 10705031078246)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031078246), received between Sep 12, 2025 and Mar 5, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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.

• MalfunctionMar 5, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT TREATMENT AND HOSPITALIZATION DUE TO PREECLAMPSIA, DIABETES IN PREGNANCY, SCAR UTERUS ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT AND HOSPITALIZATION DUE TO PREECLAMPSIA, DIABETES IN PREGNANCY, SCAR UTERUS, AND 39+2 WEEKS OF PREGNANCY. AT 9:00 A.M., THE PATIENT RECEIVED SURGERY. AT 9:55 A.M., WHEN THE DOCTOR USED THE SUTURE TO GIVE THE PUERPERA A SKIN SUTURE, THE NEEDLE AND SUTURE INTERFACE SUDDENLY BROKE, LEADING TO THE FAILURE OF THE ORIGINAL SUTURE OPERATION. WHEN THE FRACTURE OCCURRED, THE NEEDLE BODY MIGHT CAUSE SCRATCHES OR STABS TO THE SURROUNDING TISSUES. IMMEDIATELY REPORT TO THE DOCTOR TO CHECK THE INTEGRITY OF THE NEEDLE. AT THE SAME TIME, EXPLORE THE POSSIBLE DAMAGED AREA. AFTER EXPLORATION, IT WAS DETERMINED THAT THE NEEDLE WAS COMPLETE AND THERE WAS NO MISSING PART LEFT IN THE PATIENT'S BODY. THE DOCTOR IMMEDIATELY REPLACED THE NEW SUTURE TO GIVE THE PUERPERA A NEW SUTURE. 10: THE SURGICAL INCISION CLOSURE OF THE 15 MINUTE PARTURIENT IS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520912 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23788926 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23788925 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23788862 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23788855 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23788849 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23788845 ↗
• MalfunctionSep 12, 2025Break; Break

  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 BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036981 ↗