Coated VICRYL VCP751DRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031055292), received between Apr 30, 2019 and Sep 18, 2026 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827164 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, WHILE SUTURING THE UTERINE WOUND, THE SUTURE BROKE. THE DOCTOR USED OTHER SUTURE TO CONTINUE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215918 ↗
• MalfunctionMar 13, 2026Material Separation; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN SURGICAL REPAIR OF DEVIATED NASAL SEPTUM ON (B)(6) 2026 A SUTURE WAS USED. DURING THE OPERATION, IT WAS FOUND THAT THE SUTURE INTERFACE WAS ROUGH AND EASY TO FALL OFF WHEN USING SUTURE TO SUTURE THE WOUND. THE DOCTOR REPLACED THE SAME BATCH OF SUTURE AND FOUND THE SAME PROBLEM, SO OTHER SUTURE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589970 ↗
• MalfunctionDec 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTIFICIAL FEMORAL HEAD REPLACEMENT SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. TOWARDS THE END OF THE SURGERY, WHILE USING A NEEDLE TO SUTURE THE MUSCLE, THE SURGEON PULLED IT TIGHTLY AND THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, CAUSING THE NEEDLE TO ONLY BE SUTURED ONCE AND RESULTING IN WASTAGE OF CONSUMABLES. ANOTHER NEEDLE WAS REPLACED TO CONTINUE SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830605 ↗
• MalfunctionJul 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FRACTURE PROCEDURE AND SUTURE WAS USED. POST-OP, ON (B)(6) 2025 THE PATIENT'S SKIN WAS SUTURED AFTER SURGERY. THREE WEEKS LATER, WHEN THE SUTURE WAS REMOVED, THE DOCTOR FOUND THAT THE PATIENT'S WOUND HAD NOT HEALED. RE-BANDAGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 22508608 ↗
• MalfunctionJan 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C- SECTION ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196785 ↗
• MalfunctionAug 22, 2024Material Separation; Device Contaminated During Manufacture or Shipping; Material Separation; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT SUTURE WAS FOUND OXIDATION IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY. BESIDES, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED. 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 20033050 ↗
• MalfunctionAug 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. A TRANSVERSE INCISION WAS MADE IN THE LOWER SEGMENT OF THE UTERUS DURING SURGERY. DURING THE SURGICAL PROCESS, THE DOCTOR NEED TO USE SUTURE TO SUTURE THE PATIENT'S WOUND. WHEN OPENING A NEW AND COMPLETE PACKAGE OF SUTURES, AN UNKNOWN RESIDUE WAS FOUND ON THE NEEDLE. THE NURSE AND DOCTOR IMMEDIATELY REPLACED IT WITH ANOTHER PACKAGE OF SUTURE . AFTER REPLACEMENT, NO ABNORMALITIES WERE FOUND, AND THE SURGERY PROCEEDED SMOOTHLY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982563 ↗
• MalfunctionNov 21, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT UTERINE FIBROIDS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY , UTERINE BLOOD VESSELS WERE SUTURED, THE DOCTOR USED SUTURE TO PERFORM THE SUTURING. DURING THE SUTURING PROCESS,THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED , AND THE VASCULAR SUTURING WAS NOT SUCCESSFULLY COMPLETED. COMPLETE VASCULAR LIGATION AFTER REPLACING THE SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184787 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR A RIGHT PATELLAR FRACTURE ON (B)(6) 2023 AND SUTURE WAS USED TO SEW ALL LAYERS OF THE WOUND. ON THE 5TH DAY AFTER SURGERY, THE PATIENT'S WOUND WAS REDDENED AND SWOLLEN, WITH OBVIOUS REDNESS AND SWELLING AT THE SUTURE NODE WITHOUT EXUDATION. THE PATIENT HAD POST OP INFLAMMATION. THE DOCTOR ADMINISTERED IODINE, HYDROGEN PEROXIDE, AND SALINE TO CLEAN THE WOUND. THE DOCTOR CONTINUED TO ADMINISTER INTRAVENOUS ANTIBIOTICS FOR ANTI-INFLAMMATORY TREATMENT, AND INTRAVENOUS DEXAMETHASONE FOR ALLERGIC TREATMENT. THE REDNESS AND SWELLING GRADUALLY IMPROVED, NO REDNESS OR SWELLING WAS OBSERVED ON THE 10TH DAY AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Swelling/ Edema

  MAUDE report 18101414 ↗
• MalfunctionNov 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REDUCTION OF CLOSED INTERTROCHANTERIC INTRAMEDULLARY NAIL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING KNOTTING IN THE SURGERY. 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 15887758 ↗
• MalfunctionNov 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN THE SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE FELL INTO THE PATIENT, BUT WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822371 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING SEWING THE INCISION. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM 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 15821475 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN THE SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE FELL INTO THE PATIENT, BUT WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820300 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN THE SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE FELL INTO THE PATIENT, BUT WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820288 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN THE SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE FELL INTO THE PATIENT, BUT WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820105 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 10/17/2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING SEWING THE INCISION. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM 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 15820071 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN THE SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE FELL INTO THE PATIENT, BUT WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819773 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING SEWING THE INCISION. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM 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 15819028 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN THE SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE FELL INTO THE PATIENT, BUT WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818646 ↗
• MalfunctionNov 16, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SEWING THE SKIN IN SURGERY. REPLACED IT WITH ANOTHER SUTURE FROM THE SAME PACKAGE, WHICH ALSO COULD NOT BE USED NORMALLY. THE CUSTOMER FEEDBACK WAS THAT THE SUTURE BROKE EASILY WHEN IT WAS SLIGHTLY PULLED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15809671 ↗
• MalfunctionNov 16, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SEWING THE SKIN IN SURGERY. REPLACED IT WITH ANOTHER SUTURE FROM THE SAME PACKAGE, WHICH ALSO COULD NOT BE USED NORMALLY. THE CUSTOMER FEEDBACK WAS THAT THE SUTURE BROKE EASILY WHEN IT WAS SLIGHTLY PULLED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808834 ↗
• MalfunctionJul 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ARTHROPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED 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 15022840 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION AND PLATE INTERNAL FIXATION FOR BILATERAL DISTAL RADIUS FRACTURES ON (B)(6) 2021 AND SUTURE WAS USED ON THE SUBCUTANEOUS TISSUE. NINE DAYS LATER, THE PATIENT EXPERIENCED PAIN AT THE WOUND AND THE DRESSING WAS SOAKED WITH PALE YELLOW WOUND SECRETION. THE PATIENT IMMEDIATELY WENT TO THE HOSPITAL FOR REEXAMINATION, AND THE DRESSING WAS OPENED, AND A SMALL AMOUNT OF PALE YELLOW WOUND SECRETION WAS OBSERVED IN THE SURGICAL WOUNDS OF BILATERAL WRISTS, AND PARTIAL SUBCUTANEOUS SUTURES WERE EXPOSED, WITH ERYTHEMA AND INFLAMMATION AT THE STITCHES, AND POOR WOUND HEALING. WOUND DRESSING WAS CHANGED, THE WOUND WAS WASHED WITH HYDROGEN PEROXIDE AND SALINE, THE EXPOSED SUTURE WAS REMOVED, AND ORAL ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Impaired Healing; Inflammation; Pain

  MAUDE report 12738150 ↗
• MalfunctionApr 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLORECTAL SURGERY ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565715 ↗

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