Coated VICRYL VCP345H (UDI 10705031052550)Recalls & reported problems

Summary

The FDA's MAUDE database contains 405 adverse event reports that list this exact device (DI 10705031052550), received between Dec 4, 2018 and Sep 23, 2026 — classified as 1 death, 66 injuries, 338 malfunctions.

The most frequently reported specific device problem is “Break” (225 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 405 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Failure to Degrade

  Patient problems: Erythema; Impaired Healing; Inflammation

  MAUDE report 50873618 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Impaired Healing

  MAUDE report 50873449 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548713 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Right clavicle fracture surgery on (b)(6) 2026 and suture was used. The doctor used suture and the process was normal. Antibiotics were given to prevent infection after the surgery. The wound was observed to be okay after dressing change, and precautions and infection risks were informed before discharge. Post-op, the patient experienced inflammation and wound Infection. On (b)(6) 2026, the patient was found to have local redness and swelling of the right clavicle and sinus formation. After a follow-up visit to the outpatient department on (b)(6) 2026, it was recommended to be admitted to the hospital for postoperative debridement of the right clavicle fracture. After surgery, bacterial culture was taken, and the culture result was Staphylococcus aureus infection. The patient tested positive for cephalosporin skin test before surgery and was treated with clindamycin antibiotics for infection. The wound condition is still being observed and treatment is currently underway. Additional information was requested.

  Patient problems: Erythema; Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 50476665 ↗
• MalfunctionAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442355 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303370 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303361 ↗
• MalfunctionJun 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERNAL FIXATION RETENTION AND INCISION REMOVAL SURGERY FOR RIGHT CLAVICLE FRACTURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, 10 MINUTES AFTER THE PROCEDURE BEGAN, WHEN THE MUSCLE WAS SUTURED HALFWAY, THE NEEDLE PULL OFF ISSUE HAPPENED AND COULD NOT BE USED NORMALLY, SO IT WAS REPLACED IMMEDIATELY, AND THE SURGERY WENT SMOOTHLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580900 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERNAL FIXATION SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A FRACTURE OF THE LEFT TIBIAL PLATEAU. THE DOCTOR PERFORMED AN INTERNAL FIXATION SURGERY USING A TIBIAL PLATEAU LOCKING STEEL PLATE, AND THE SURGICAL PROCESS WENT SMOOTHLY. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING AND WOUND SECRETION SEVEN DAYS AFTER THE SURGERY, THE PATIENT'S INCISION HEALING WAS POOR, WITH LEAKAGE AND BACTERIAL CULTURE INDICATING A DRUG-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT WAS READMITTED AND UNDERWENT REMOVAL OF INTERNAL FIXATION DEVICES, FOLLOWED BY DEBRIDEMENT AND ANTI INFECTION TREATMENT. THE INFECTION SYMPTOMS HAVE NOW IMPROVED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing; Unspecified Infection

  MAUDE report 25408950 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ROBOT ASSISTED OSTEOTOMY, CORRECTION, BONE GRAFT FUSION, AND INTERNAL FIXATION SURGERY FOR SCOLIOSIS POSTERIOR APPROACH ON (B)(6) 2026 AND SUTURE WAS USED. THE SURGERY WENT SMOOTHLY AND THE PATIENT WAS DISCHARGED. NINE DAYS AFTER SURGERY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO POSTOPERATIVE WOUND INFECTION. ON THE FIFTH DAY AFTER ADMISSION, THE WOUND WAS CULTURED FOR BACTERIA AND FOUND TO BE INFECTED WITH ESCHERICHIA COLI. THE PATIENT RECEIVED SURGERY AGAIN. ANTI INFECTION TREATMENT WAS GIVEN, AND THE WOUND WAS DISINFECTED, DRESSING CHANGED, AND SUTURED. AFTER 42 DAYS IN THE HOSPITAL, THE PATIENT'S CONDITION WAS STABLE AT PRESENT, AND WILL CONTINUE DRESSING CHANGE TREATMENT AFTER DISCHARGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Bacterial Infection

  MAUDE report 25164869 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANKLE TALOFIBULAR ANTERIOR LIGAMENT REPAIR SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE SURGERY WENT SMOOTHLY AND THE PATIENT WAS DISCHARGED. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING, INFLAMMATION AND WOUND SECRETION. FORTY-NINE DAYS AFTER SURGERY, THE WOUND DID NOT HEAL, WITH A SMALL AMOUNT OF EXUDATION AND REDNESS. DUE TO POOR WOUND HEALING AFTER SURGERY, THE PATIENT WAS READMITTED FOR DEBRIDEMENT AND DRESSING CHANGE AND ANCHOR NAIL REMOVAL AND ANTI-INFECTION TREATMENT. THE SECOND SURGERY WAS A DEBRIDEMENT AND INTERNAL FIXATION REMOVAL SURGERY. THE RELEVANT DEPARTMENTS WERE ASKED TO CONSULT BEFORE FURTHER OPERATION. FIFTY-FIVE DAYS AFTER THE FIRST SURGERY, THE WOUND WAS WELL BANDAGED, DRY, AND HAD NO EXUDATION. AFTER DISCHARGE, THE WOUND CONTINUED TO UNDERGO REGULAR DRESSING CHANGES. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 25112920 ↗
• MalfunctionApr 22, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. INCORRECT QUANTITY-MISSING PACKAGES. BEFORE PREPARING TO USE, IT WAS FOUND THAT THERE WAS 1 PACKAGE OF PRODUCT LESS THAN EXPECTED IN THE BOX. THERE SHOULD BE 36 PACKAGE OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY 35 PACKAGE OF PRODUCTS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953759 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR SPINE POSTERIOR ROBOT ASSISTED DISCECTOMY, DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. THE PATIENT WAS ADMITTED WITH LUMBAR DISC HERNIATION AND UNDERWENT ROUTINE PREOPERATIVE EXAMINATIONS TO RULE OUT SURGICAL CONTRAINDICATIONS. THE PATIENT UNDERWENT SURGERY AND THE DOCTOR USED A FUSION CAGE FOR INTERBODY BONE GRAFTING DURING THE OPERATION. INTRAOPERATIVE USE OF FLUID GELATIN TO STOP BLEEDING. THE PATIENT WAS GIVEN NUTRITIONAL SUPPORT AND ANTI INFECTIVE TREATMENT AFTER SURGERY, AND REMOVED THE WOUND DRAINAGE TUBE WHEN THE DRAINAGE VOLUME DECREASES. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING AND WOUND SECRETION. ON THE (B)(6) DAY AFTER SURGERY, THE PATIENT FOUND A SMALL AMOUNT OF YELLOW WHITE PURULENT FLUID OOZING OUT FROM THE WOUND DURING DRESSING CHANGE, AND THE WOUND PARTIALLY CRACKED, WITH POOR WOUND HEALING. ON THE (B)(6) DAY AFTER SURGERY, THE PATIENT WAS READMITTED AND THE DOCTOR PRESCRIBED DAILY DRESSING CHANGES. BASED ON THE RESULTS OF METAGENOMIC TESTING, THE PATIENT CONTINUED WITH ANTI INFECTIVE TREATMENT. ADJUST THE TREATMEN

  Patient problems: Impaired Healing; Purulent Discharge; Wound Dehiscence

  MAUDE report 24912102 ↗
• MalfunctionFeb 23, 2026Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025, AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED TO 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 24414827 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHILE SUTURING THE PATIENT'S WOUND, IT WAS FOUND THAT THE NEEDLE TIP IN FRONT OF THE SUTURE NEEDLE WITH THE SUTURE WAS BROKEN. IT WAS IMMEDIATELY REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224740 ↗
• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF INTERNAL FIXATION DEVICE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT THE END OF THE SURGERY, WHEN THE SUTURE WAS PULLED, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE USE WAS IMMEDIATELY STOPPED AND A NEW SUTURE WAS REPLACED. THE SURGERY WAS NORMAL AND DID NOT AFFECT THE PROGRESS OF THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205238 ↗
• MalfunctionJan 26, 2026Break

  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 24179905 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN TWICE DURING THE CLOSURE OF THE ABDOMINAL FASCIA LAYER, AND OTHER SUBSTITUTE SUTURE WAS REPLACED TO CONTINUE SUTURING, WHICH CAUSED THE PATIENT'S OPERATION TIME TO BE PROLONGED AND INCREASED THE PATIENT'S OPERATION RISK. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179847 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN MYOMECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087296 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN MYOMECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087263 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. 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 24086343 ↗
• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. 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 24086138 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2025 SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. 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 24085372 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2025 SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. 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 24085367 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2025 SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. 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 24085357 ↗

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