Coated VICRYL VCP493H (UDI 10705031150034)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031150034), received between Aug 26, 2024 and Jun 29, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Material Separation” (24 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026, AND SUTURE WAS USED. AFTER SURGICALLY REMOVING A SKIN MASS ON THE PATIENT'S RIGHT FACE, THE DOCTOR USED SUTURE TO SUTURE THE INCISION. AT THE BEGINNING OF THE FIRST STITCH, THE NEEDLE AND SUTURE LOOSENED AND FELL OFF. A NEW SUTURE WAS OPENED, AND WHEN THE DOCTOR USED A NEEDLE HOLDER TO REMOVE THE SUTURE, THE NEEDLE AND SUTURE LOOSENED AND FELL OFF AGAIN. AFTER THE THIRD OPENING OF THE SUTURE, THE MATERIAL WAS INTACT AND THE WOUND WAS SUCCESSFULLY SUTURED. AT PRESENT, NO DIRECT HARM HAS BEEN CAUSED TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652529 ↗
• MalfunctionMay 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. THE PATIENT HAD A SKIN LACERATION AROUND THE LOWER LIP AND UNDERWENT SUTURING. DURING THE SUTURING PROCESS, THE NEEDLE PULL OFF ISSUE HAPPENED. NEW SUTURE WAS REPLACED FOR SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229244 ↗
• MalfunctionMay 1, 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 25055799 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY 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 IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 36 REPRESENTATIVE SAMPLES FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055772 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN PLASTIC SURGERY 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. THERE WILL RETURN 36 REPRESENTATIVE SAMPLES FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055748 ↗
• MalfunctionApr 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT SUFFERED A FACIAL SKIN LACERATION DUE TO TRAUMA. THE DOCTOR PERFORMED SUTURING ON THE PATIENT, BUT DURING THE SUTURING PROCESS, THE NEEDLE AND SUTURE BROKE, MAKING IT IMPOSSIBLE TO CONTINUE SUTURING. THE DOCTOR REPLACED THE SUTURE WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044273 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR PERFORMED A LIP LACERATION SUTURE ON THE PATIENT, USING A NEEDLE HOLDER TO CLAMP THE NEEDLE. AFTER SUTURING INTO THE SKIN, THE NEEDLE AND SUTURE BROKE, AND THE DOCTOR REPLACED THE SUTURE WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017762 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE PATIENT HAD A COMPOUND INJURY WITH A FIVE TO SIX CENTIMETER TEAR ON THE EYELID. THE OPHTHALMOLOGIST WENT TO THE INTENSIVE CARE UNIT TO SUTURE THE TEAR ON THE EYELID FOR THE PATIENT. THE FIRST SUTURE WAS USED FOR SUTURING, AND TWO STITCHES WERE SUTURED. THE SUTURE AND NEEDLE BROKE, AND THE SECOND SUTURE WAS OPENED FOR USE. THE SECOND SUTURE AND NEEDLE WERE DISCONNECTED, SO THE THIRD SUTURE WAS REPLACED FOR SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966849 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE PATIENT HAD A COMPOUND INJURY WITH A FIVE TO SIX CENTIMETER TEAR ON THE EYELID. THE OPHTHALMOLOGIST WENT TO THE INTENSIVE CARE UNIT TO SUTURE THE TEAR ON THE EYELID FOR THE PATIENT. THE FIRST SUTURE WAS USED FOR SUTURING, AND TWO STITCHES WERE SUTURED. THE SUTURE AND NEEDLE BROKE, AND THE SECOND SUTURE WAS OPENED FOR USE. THE SECOND SUTURE AND NEEDLE WERE DISCONNECTED, SO THE THIRD SUTURE WAS REPLACED FOR SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966847 ↗
• MalfunctionApr 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. THE PATIENT HAD A SKIN LACERATION AROUND THE LOWER LIP AND UNDERWENT SUTURING. DURING THE SUTURING PROCESS, THE NEEDLE PULL OFF ISSUE HAPPENED. NEW SUTURE WAS REPLACED FOR SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938855 ↗
• MalfunctionDec 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE DETACHED FROM THE SUTURE DURING SUTURING WOULD CLOSURE AT OPD SURGERY, THEN ASSISTANCE WAS OPEN A NEW SUTURE FROM DIFFERENT LOT TO CONTINUE PROCEDURE UNTIL COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756586 ↗
• MalfunctionDec 2, 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 IN SURGERY. TOTAL 8 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23698241 ↗
• MalfunctionDec 2, 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 IN SURGERY. TOTAL 8 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23698240 ↗
• MalfunctionDec 2, 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 IN SURGERY. TOTAL 8 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23698239 ↗
• MalfunctionDec 2, 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 IN SURGERY. TOTAL 8 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23698235 ↗
• MalfunctionDec 2, 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 IN SURGERY. TOTAL 8 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23698234 ↗
• MalfunctionDec 2, 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 IN SURGERY. TOTAL 8 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23698066 ↗
• MalfunctionDec 2, 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 IN SURGERY. TOTAL 8 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23698063 ↗
• MalfunctionDec 2, 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 IN SURGERY. TOTAL 8 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 23698062 ↗
• MalfunctionNov 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN SUTURING THE INCISION FOR THE PATIENT, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. REPLACED WITH A NEW ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512023 ↗
• MalfunctionOct 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE 1 ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE THE REMAINING 33 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266621 ↗
• MalfunctionOct 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE 1 ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE THE REMAINING 33 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266619 ↗
• MalfunctionJun 20, 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 PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 22297130 ↗
• MalfunctionJun 18, 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 PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER THREE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER FIVE TO CONTINUE THE SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED 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 22283207 ↗
• MalfunctionJun 18, 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 PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER THREE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER FIVE TO CONTINUE THE SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED 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 22283199 ↗