Coated VICRYL VCP945H (UDI 10705031056121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10705031056121), received between Jul 12, 2018 and Jun 29, 2026 — classified as 27 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS FOUND THAT THE STERILE MATERIAL PACKAGING WAS BROKEN AND UNUSABLE UPON ARRIVAL, AND THE ITEM WAS RETURNED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659781 ↗
• MalfunctionSep 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED NO ABNORMALITY WAS FOUND WHEN THE PACKAGE WAS OPENED FOR INSPECTION OF THE SUTURE BEFORE SUTURING. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. A NEW SUTURE WAS USED INSTEAD TO CONTINUE THE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007718 ↗
• MalfunctionJul 31, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION SURGERY ON AN UNKNOWN DATE SUTURE WAS USED. POST-OP, THE DOCTOR SUTURED THE PATIENT'S WOUND AFTER SURGERY. ON (B)(6) 2025 AND AFTER ONE MONTH, THE PATIENT'S WOUND HAD HEALED AND THE SUTURE WAS NOT ABSORBED. THE DOCTOR USED TWEEZERS TO PINCH OUT THE SUTURE, AND THE PATIENT'S WOUND WAS NOT SWOLLEN OR RED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680483 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AROUND 10:10, THE SUTURE THREAD WAS SENT INTO THE ABDOMINAL CAVITY TO PREPARE FOR SUTURING THE UTERINE STUMP. THE SURGEON WAITED FOR ABOUT 10 MINUTES FOR THE VAGINAL SUTURING DOCTOR TO PREPARE FOR SUTURING THE ANTERIOR AND POSTERIOR WALLS OF THE VAGINA. WHEN PREPARING TO SUTURE THE UTERUS, IT WAS FOUND THAT ONLY THE SUTURE DID NOT HAVE A NEEDLE. THE SURGEON IMMEDIATELY SEARCHED THE ABDOMINAL CAVITY AND FOUND IT AROUND 10:30. IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND A NEW SUTURE THREAD WAS REPLACED TO CONTINUE THE LAPAROSCOPIC HYSTERECTOMY AND VAGINAL WALL REPAIR SURGERY. THIS EVENT HAS LED TO THE RISK OF LEAVING THE BODY BEHIND AND PROLONGED THE SURGERY TIME. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22542258 ↗
• MalfunctionJul 3, 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, EMAIL FROM CHARGE NURSE: " GOOD DAY! I WAS TOLD TO INFORM YOU AND THE MANAGEMENT OF SUTURES THAT WERE FOUND TO BE FAULTY. ONE OF THE SUTURES HAD THE THREAD ATTACHED LOOSELY ON THE NEEDLE UPON OPENING FROM THE PACKET AND THE OTHER SUTURE DETACHED ON FIRST STITCHING BY THE SURGEON. BOTH ARE FROM THE SAME BOX, PHOTO ATTACHED." NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396318 ↗
• InjuryMay 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHILDBIRTH DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED, THE MOTHER GAVE BIRTH TO A BABY AND HAD A FIRST-DEGREE PERINEAL LACERATION. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING. THE PATIENT WAS ADMITTED TO A POSTPARTUM CARE CENTER AFTER DELIVERY AND THE SUTURE WAS NOT ABSORBED 20 DAYS AFTER DELIVERY. THE MOTHER FELT UNCOMFORTABLE AND WAS COMFORTED. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGERY UNDER ROUTINE DISINFECTION, ABSORBABLE SUTURE REMOVAL SURGERY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Impaired Healing

  MAUDE report 21952869 ↗
• MalfunctionMar 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. THE OPERATING ROOM NURSE FOUND RUST ON THE NEEDLE WHILE OPENING A PACKAGE OF SUTURE AND REPLACED IT WITH ANOTHER PACKAGE OF SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665601 ↗
• MalfunctionJan 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE END OF THE NEEDLE AFTER BEING REMOVED FROM THE SKIN, AND THE SUTURE WAS IMMEDIATELY REPLACED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173024 ↗
• MalfunctionJan 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING SUBCUTANEOUS TISSUE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE FIRST STITCH. A NEW SUTURE WAS IMMEDIATELY REPLACED, WHICH RESULTED IN AN ADDITIONAL 2 MINUTES OF SURGICAL TIME. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130128 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. THEY HAD 4 SUTURES EARLIER IN THE WEEK BREAK IN THE UNKNOWN CASE WHEN TRYING TO HAND TIE. NO PATIENT HARM REPORTED. THE 4 THAT HAD BROKEN WERE DISCARDED BUT THE REP WILL RETURN 2 FROM THE SAME LOT THAT WERE UNOPENED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920247 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. THEY HAD 4 SUTURES EARLIER IN THE WEEK BREAK IN THE UNKNOWN CASE WHEN TRYING TO HAND TIE. NO PATIENT HARM REPORTED. THE 4 THAT HAD BROKEN WERE DISCARDED BUT THE REP WILL RETURN 2 FROM THE SAME LOT THAT WERE UNOPENED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917105 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. THEY HAD 4 SUTURES EARLIER IN THE WEEK BREAK IN THE UNKNOWN CASE WHEN TRYING TO HAND TIE. NO PATIENT HARM REPORTED. THE 4 THAT HAD BROKEN WERE DISCARDED BUT THE REP WILL RETURN 2 FROM THE SAME LOT THAT WERE UNOPENED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916646 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. THEY HAD 4 SUTURES EARLIER IN THE WEEK BREAK IN THE UNKNOWN CASE WHEN TRYING TO HAND TIE. NO PATIENT HARM REPORTED. THE 4 THAT HAD BROKEN WERE DISCARDED BUT THE REP WILL RETURN 2 FROM THE SAME LOT THAT WERE UNOPENED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916474 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE AT THE LEVEL OF UTERINE EMBEDDING. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610632 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE AT THE LEVEL OF UTERINE EMBEDDING. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610627 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE LEVEL OF UTERINE EMBEDDING. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577075 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE LEVEL OF UTERINE EMBEDDING. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577074 ↗
• InjuryOct 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY AND ABDOMINOPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND ISSUE/DEHISCENCE THAT REQUIRED FURTHER SURGERY AND SCAR REVISIONS AS A RESULT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 17907170 ↗
• InjuryOct 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY AND ABDOMINOPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND ISSUE/DEHISCENCE THAT REQUIRED FURTHER SURGERY AND SCAR REVISIONS AS A RESULT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 17907168 ↗
• InjuryOct 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY AND ABDOMINOPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND ISSUE/DEHISCENCE THAT REQUIRED FURTHER SURGERY AND SCAR REVISIONS AS A RESULT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 17907157 ↗
• InjuryOct 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY AND ABDOMINOPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND ISSUE/DEHISCENCE THAT REQUIRED FURTHER SURGERY AND SCAR REVISIONS AS A RESULT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 17907153 ↗
• InjuryOct 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY AND ABDOMINOPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND ISSUE/DEHISCENCE THAT REQUIRED FURTHER SURGERY AND SCAR REVISIONS AS A RESULT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 17906888 ↗
• InjuryOct 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY AND ABDOMINOPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND ISSUE/DEHISCENCE THAT REQUIRED FURTHER SURGERY AND SCAR REVISIONS AS A RESULT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pocket Erosion; Scar Tissue; Wound Dehiscence

  MAUDE report 17906786 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THREE WEEKS POST OP, THE PATIENT HAD TO BE BROUGHT BACK AND TREATED FOR WOUND DEHISCENCE. THERE WAS NO UPDATE ON THE PATIENT AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17669265 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THREE WEEKS POST OP, THE PATIENT HAD TO BE BROUGHT BACK AND TREATED FOR WOUND DEHISCENCE. THERE WAS NO UPDATE ON THE PATIENT AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17669259 ↗

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