Coated VICRYL VCP397H (UDI 10705031149946)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031149946), received between May 1, 2025 and Jun 1, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO AN OPEN INJURY TO THE RIGHT FOOT. DURING THE PROCESS OF SUTURING THE PATIENT, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND REPLACED THEM WITH A NEW SUTURE OF THE SAME BATCH. THE SUTURE WENT SMOOTHLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348731 ↗
• MalfunctionMay 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING 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 25241131 ↗
• MalfunctionMay 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHEN SUTURING THE SKIN DURING THE SURGERY, THE NEEDLE PULL OFF ISSUE HAPPENED, THE DOCTOR ACTED GENTLY WITHOUT VIOLENCE. THE SUTURE WAS REPLACED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148422 ↗
• MalfunctionApr 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO AN OPEN FOREARM INJURY. DURING THE PROCESS OF SUTURING THE PATIENT, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED , AND THE DOCTOR REPLACED IT WITH A NEW SUTURE OF THE SAME BATCH NUMBER. THE SUTURE WENT SMOOTHLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897436 ↗
• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEBACEOUS GLAND CYST PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. DURING THE PROCESS OF SUTURING THE PATIENT, THE SUTURE AND NEEDLE WERE BROKEN (THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE OPERATION). A NEW SUTURE OF THE SAME BATCH WAS REPLACED, AND THE SUTURING WENT SMOOTHLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24732696 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY AND BILATERAL ADNEXECTOMY UNDER GENERAL ANESTHESIA ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE FINAL SUBCUTANEOUS INJECTION, THE DOCTOR DISCOVERED THAT THE NEEDLE HAD BROKEN ABOUT 1CM BENEATH THE PATIENT'S SKIN. DOCTOR REPORTED TO THE CHIEF SURGEON AND FIRST CONDUCTED AN ULTRASOUND EXAMINATION, BUT THE SEARCH WAS UNSUCCESSFUL. LATER, DOCTOR USED A C-ARM MACHINE TO EXPLORE THE MUSCLE LAYER AND FOUND THE BROKEN NEEDLE, WHICH WAS THEN REMOVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24663502 ↗
• MalfunctionFeb 11, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317343 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING INTRADERMAL SUTURING OF A PATIENT WITH SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, CAUSING THE NEEDLE TO REMAIN IN THE PATIENT'S BODY. THE NEEDLE WAS TAKEN OUT AND REPLACED WITH A NEW SUTURE FOR SUTURING. RESULTING IN PROLONGED EXPOSURE OF THE PATIENT'S WOUND, AFFECTING WOUND HEALING AND INCREASING PATIENT PAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Impaired Healing; Pain

  MAUDE report 23879187 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, AFTER USING SUTURE TO SEW ONE STITCH, THE SUTURE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790716 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE DOCTOR WAS SUTURING THE WOUND, THE PROBLEM OF PULLING OFF SUTURE NEEDLE SUDDENLY HAPPENED AND WAS IMMEDIATELY STOPPED AND REPLACED WITH A NEW SUTURE. AFTER CAREFUL OBSERVATION OF THE PROBLEMATIC PRODUCT, IT WAS FOUND THAT THE NEEDLE HOLE OF THE SUTURE NEEDLE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649057 ↗
• MalfunctionJul 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PREGNANT WOMAN WAS PREPARED FOR SURGERY IN THE OPERATING ROOM AT 9: 00 AM. THE HAND WASHING NURSE FOUND THAT THERE WAS A HAIR ABOUT 3CM LONG INSIDE THE SUTURE WHEN CHECKING THE SURGICAL ITEMS BEFORE SURGERY. IMMEDIATELY REPLACED IT AFTER FINDING IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575834 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 24/02/2025 AND SUTURE WAS USED. DURING THE PROCEDURE, BREAKAGE NEEDLE. THIS CASE IS FROM HEALTH AUTHORITY. THE NEEDLE TIP BROKE DURING USE AND WAS REPLACED IN TIME. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943118 ↗