Coated VICRYL VCP359H (UDI 10705031052734)Recalls & reported problems

Summary

The FDA's MAUDE database contains 315 adverse event reports that list this exact device (DI 10705031052734), received between Feb 5, 2018 and Sep 25, 2026 — classified as 1 death, 27 injuries, 287 malfunctions.

The most frequently reported specific device problem is “Break” (189 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 315 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50901208 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Impaired Healing; Necrosis

  MAUDE report 50889601 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent surgical treatment to fix the tibial plateau fracture on (b)(6) 2026 and suture was used. The patient was successfully discharged from the hospital. The patient had poor wound healing after surgery, accompanied by yellow white discharge, and was admitted again with poor wound healing after tibial surgery. The patient underwent wound debridement and suturing surgery, and the wound is now healing well. No redness, swelling or exudation, the wound suture was not removed . And the patient was discharged. Additional information was requested.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 50876994 ↗
• MalfunctionMay 12, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHEN PREPARING FOR USE BEFORE SURGERY, IT WAS FOUND THAT THE PACKAGE SEAL IS IN OPEN STATUS. NEED INVESTIGATION WHAT'S WRONG WITH THE SEAL. 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 25149947 ↗
• MalfunctionMar 3, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. 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 24498543 ↗
• MalfunctionFeb 25, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NEEDLE SURFACE IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446385 ↗
• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PREGNANCY. ON THE SECOND DAY AFTER ADMISSION, AT 15:00, DURING THE SURGICAL PROCESS OF SUTURING THE UTERUS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE AFTER DISCOVERING THIS SITUATION, WHICH RESULTED IN AN EXTENSION OF THE SURGICAL TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290978 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON 8-JAN2026 AND SUTURE WAS USED. 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. THE NEEDLE DID NOT FELL INTO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236468 ↗
• MalfunctionJan 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE OPERATION OF SUTURING THE PERITONEUM, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SUTURE WAS IMMEDIATELY REPLACED TO CONTINUE SUTURING THE PERITONEUM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118269 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL KNEE JOINT SURFACE REPLACEMENT SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. THE WOUND HEALING WAS SLOW AND THE INCISION WAS RED AND SWOLLEN AFTER THE SURGERY. IT WAS CONSIDERED THAT THERE WAS A KNOT REACTION. AFTER ACTIVELY CHANGING THE DRESSING, THE CONDITION IMPROVED WITHOUT ANY SPECIAL DISCOMFORT. ON (B)(6) 2025, THE PATIENT WAS ADMITTED AGAIN DUE TO PAIN IN BOTH KNEES AND THE PATIENT RECOVERED WELL AFTER THE SURGERY. REGULAR FOLLOW-UP EXAMINATIONS DURING THIS PERIOD SHOWED GOOD RECOVERY AFTER THE DOUBLE KNEE JOINT REPLACEMENT SURGERY. CONSERVATIVE PHYSICAL THERAPY AND MEDICATION TREATMENT WERE ADOPTED, AND THE PATIENT IMPROVED AND WAS DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Impaired Healing; Pain; Swelling/ Edema

  MAUDE report 24084497 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ARTIFICIAL KNEE REPLACEMENT SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. 15 DAYS AFTER THE SURGERY, THE WOUND HEALING WAS SLOW. POOR WOUND HEALING. AFTER ACTIVELY CHANGING THE DRESSING, THE WOUND HEALING WAS GOOD. THE PATIENT WAS ADMITTED ON (B)(6) 2025, DUE TO POSTOPERATIVE PAIN AFTER BILATERAL KNEE REPLACEMENT SURGERY FOR MORE THAN ONE MONTH. THE POSTOPERATIVE RECOVERY WAS SATISFACTORY, AND REGULAR FOLLOW-UP EXAMINATIONS SHOWED GOOD RECOVERY AFTER BOTH KNEE ARTHROPLASTY. THE PATIENT HAS BEEN IN THE RECOVERY PERIOD FOR ABOUT A YEAR SINCE THE SURGERY AND COMPLAINED OF WORSENING PAIN DURING PROLONGED WALKING. THERE WAS NO PAIN DURING SHORT WALKS OR REST. THE CURRENT KNEE JOINT PAIN IS CONSIDERED TO BE RELATED TO THE PATIENT'S LONG-TERM WALKING IN DAILY LIFE AFTER SURGERY, AND THE KNEE JOINT PAIN IS NOT RELATED TO ADVERSE REACTIONS OF THE EQUIPMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Pain

  MAUDE report 24084485 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER SEGMENT CESAREAN SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 10:35, THE CHIEF SURGEON PERFORMED LOWER SEGMENT CESAREAN SECTION SURGERY ON THE PREGNANT WOMAN AND FOUND THAT THE BOTTOM OF THE NEEDLE BODY CLAMPED ON THE NEEDLE HOLDER WAS SEPARATED FROM THE POSITION WHERE THE SUTURE WAS CONNECTED, MAKING IT UNUSABLE. A NEW SUTURE WAS REPLACED AND IT CAN BE USED NORMALLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045430 ↗
• MalfunctionDec 19, 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 FIRST LAYER OF THE UTERUS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. DUE TO DELAYED SUTURING, THE DURATION OF UTERINE BLEEDING WAS PROLONGED. THERE WERE NO POST-OPERATIVE COMPLICATIONS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23851887 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGICAL PROCESS, SUTURE WAS REQUIRED FOR SUTURING. WHEN USING A NEEDLE HOLDER TO CLAMP THE SUTURE AND GENTLY PULLING IT, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. REPLACED THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542003 ↗
• MalfunctionSep 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER ABDOMINAL CESAREAN SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE HIGH LIGATION OF THE HERNIA SAC DURING THE OPERATION, THE DOCTOR TOOK A SUTURE AND WHEN KNOTTING IT, THE SUTURE BROKE. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE IN THE SAME PACKAGE, BUT IT STILL BROKE. THE DOCTOR REPLACED THE SUTURE IN ANOTHER PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968765 ↗
• MalfunctionJul 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE PULL OFF ISSUE HAPPENED AS SOON AS THE PUNCTURE DEVICE ENTERED THE ABDOMINAL CAVITY, AND A FULL ABDOMINAL EXAMINATION WAS PERFORMED IMMEDIATELY UNDER LAPAROSCOPY. THERE IS A RISK OF BEING LEFT IN THE BODY, WHICH MAY CAUSE SERIOUS HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630967 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, TIP OF NEEDLE SNAPPED OFF DURING USE. TIP FOUND AND SUTURE REMOVED FROM USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22515688 ↗
• MalfunctionJun 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER SEGMENT CESAREAN SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE UTERUS DURING CESAREAN SECTION, SUTURE WAS USED TO SUTURE THE WOUND. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SUTURE WAS REPLACED IN A TIMELY MANNER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310050 ↗
• MalfunctionJun 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN 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 . 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 22187460 ↗
• MalfunctionJun 11, 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 DURING THE SURGICAL SUTURE PROCESS. 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 22183834 ↗
• MalfunctionJun 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUBTOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR UTERINE FIBROIDS AND UNDERWENT SURGERY. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SUTURE WAS IMMEDIATELY REPLACED TO COMPLETE THE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127448 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNDER COMBINED SPINAL EPIDURAL ANESTHESIA AND NERVE BLOCK ANESTHESIA, A TRANSVERSE INCISION CESAREAN SECTION IN THE LOWER SEGMENT OF THE UTERUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DUE TO THE REQUIREMENT FOR UNDER COMBINED SPINAL EPIDURAL ANESTHESIA AND NERVE BLOCK ANESTHESIA, A TRANSVERSE INCISION CESAREAN SECTION IN THE LOWER SEGMENT OF THE UTERUS SURGERY, THE PATIENT UNDERWENT SURGERY. WHEN SUTURING THE UTERINE MUSCLE LAYER, THE SUTURE BROKE AND WAS REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091786 ↗
• MalfunctionApr 28, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE LAPAROSCOPIC SURGERY OPERATION, THE NEEDLE BENT AND BROKE DURING THE SUTURING OF THE UTERINE INCISION. THE NEEDLE WAS COMPLETELY REMOVED FROM THE ABDOMINAL CAVITY AND REPLACED FOR RE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919328 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL CLOSURE PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING ABDOMEN, TIP OF NEEDLE HAS BROKEN OFF. SURGEON'S AND SCRUB TEAM UNABLE TO LOCATE TIP OF NEEDLE. ABDOMEN WAS WASHED OUT WITH IRRIGATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21634612 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY 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 21632368 ↗

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