Coated VICRYL VCP310H (UDI 10705031052178)Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 10705031052178), received between Sep 28, 2018 and Sep 1, 2026 — classified as 11 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Material Separation” (46 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The needle pulled off. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541955 ↗
• MalfunctionAug 31, 2026Material Frayed; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532470 ↗
• MalfunctionAug 31, 2026Material Frayed; Material Integrity Problem

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The suture was loosely woven and not smooth when the surgeon sew the tissue. Changed another one to complete the surgery. Total 3 products have same issue. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532381 ↗
• MalfunctionAug 31, 2026Material Frayed; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532366 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAXILLOFACIAL TUMOR RESECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236067 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE BROKE OFF FROM THE NEEDLE FOR THREE PATIENTS. THEY OPENED A SECOND SUTURE BECAUSE IT BROKE OFF EXACTLY BY THE NEEDLE WHILST THE DOCTOR SUTURED THE TISSUE TOGETHER NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075273 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BREAKS OFF FROM THE NEEDLE FOR THREE PATIENTS. THEY OPENED A SECOND SUTURE BECAUSE IT BROKE OFF EXACTLY BY THE NEEDLE WHILST THE DOCTOR SUTURED THE TISSUE TOGETHER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066682 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BREAKS OFF FROM THE NEEDLE FOR THREE PATIENTS. THEY OPENED A SECOND SUTURE BECAUSE IT BROKE OFF EXACTLY BY THE NEEDLE WHILST THE DOCTOR SUTURED THE TISSUE TOGETHER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066667 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SECONDARY CESAREAN SECTION OF LOWER SEGMENT OF UTERUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGICAL PROCEDURE WENT SMOOTHLY. WHEN SUTURING THE SKIN, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR IMMEDIATELY USED ANOTHER SUTURE TO CONTINUE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729855 ↗
• MalfunctionDec 4, 2025Break; Break

  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 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. 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 23720511 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGICAL RESECTION OF A SKIN TUMOR ON (B)(6) 2025 AND SUTURE WAS USED. ONE WEEK LATER, THERE WAS REDNESS AND SWELLING, SLIGHT PAIN, INFLAMMATION AND NO OBVIOUS SIGNS OF INFECTION SUCH AS SUBCUTANEOUS FLUID ACCUMULATION OR ABSCESS AT THE INCISION SITE. AFTER THE PATIENT'S VISIT, THE DOCTOR ADMINISTERED HELIUM NEON LASER, DRESSING CHANGE WET COMPRESS TREATMENT, AND WOUND TRACKING OBSERVATION. ON THE 14TH DAY AFTER SURGERY, THE OUTER LAYER OF THE SUTURE WAS ROUTINELY REMOVED, AND THE REDNESS, SWELLING, AND PAIN WERE SIGNIFICANTLY REDUCED WITHOUT ANY OTHER OBVIOUS ABNORMALITIES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Pain; Swelling/ Edema

  MAUDE report 23633703 ↗
• MalfunctionNov 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 18:45, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SKIN WAS CONTINUOUSLY SUTURED WITH SUTURE, RESULTING IN INCOMPLETE CONTINUOUS SUTURING. THE SUTURE WAS REPLACED AND RE SUTURED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593282 ↗
• MalfunctionOct 15, 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 COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300029 ↗
• MalfunctionOct 10, 2025Material Separation; Defective Component; Dull, Blunt; Structural Problem; Material Integrity Problem; Material Separation; Defective Component; Dull, Blunt; Structural Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF THE NEEDLE. THE SURGEON NOTED THAT THE NEEDLE WAS NOT AS SHARP AS THOSE FROM PREVIOUS BATCHES, FELT THINNER, AND SEEMED WEAKER AND LESS STABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266981 ↗
• MalfunctionOct 10, 2025Material Separation; Defective Component; Dull, Blunt; Structural Problem; Material Twisted/Bent; Material Separation; Defective Component; Dull, Blunt; Structural Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF THE NEEDLE. THE SURGEON NOTED THAT THE NEEDLE WAS NOT AS SHARP AS THOSE FROM PREVIOUS BATCHES, FELT THINNER, AND SEEMED WEAKER AND LESS STABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266978 ↗
• MalfunctionOct 9, 2025Material Separation; Defective Component; Dull, Blunt; Structural Problem; Material Integrity Problem; Material Separation; Defective Component; Dull, Blunt; Structural Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF THE NEEDLE. THE SURGEON NOTED THAT THIS NEEDLE FELT THINNER AND LESS DURABLE THAN THOSE PREVIOUSLY USED, LACKING SHARPNESS AND STABILITY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257721 ↗
• MalfunctionSep 8, 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, WHEN THE SUTURE WAS USED FOR SUTURING THE SKIN, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND A NEW SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994703 ↗
• MalfunctionJul 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED ON THE WOUND. DURING THE PROCEDURE, WHEN THE DOCTOR USED A NEEDLE HOLDER TO CLAMP THE NEEDLE FOR OPERATION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, CAUSING THE NEEDLE AND SUTURE TO SEPARATE. THE SURGERY WAS SUSPENDED, AND THE NEEDLE WAS CLAMPED ON THE NEEDLE HOLDER TO CHECK ITS INTEGRITY. THE DOCTOR REPLACED THE NEEDLE WITH A NEW ONE TO CONTINUE SUTURING, WHICH AFFECTED THE PROGRESS OF THE SURGERY . THE SURGERY WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22620987 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION 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 AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472928 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION 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 AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472916 ↗
• MalfunctionJul 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR RESECTION SURGERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382756 ↗
• MalfunctionJul 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR RESECTION SURGERY PROCEDURE ON 5/29/2025 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382602 ↗
• MalfunctionMay 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION 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 THE DOCTOR WAS USING IT TO SEW THE PATIENT'S SKIN. THE DOCTOR IMMEDIATELY STOPPED USING THE PROBLEMATIC SUTURE AND REPLACED IT WITH NEW ONE OF THE SAME TYPE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003639 ↗
• MalfunctionJan 14, 2025Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. BESIDES, THERE WAS SUTURE ENDS AT THE JUNCTION OF THE NEEDLE AND SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149670 ↗
• MalfunctionJan 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126912 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and