Coated VICRYL VCP714DRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10705031055018), received between Jun 18, 2019 and Apr 20, 2026 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE TIP HAD BROKEN WHEN SEWING 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 24926918 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. IT WAS FOUND THAT THE SUTURE BROKE DURING SURGERY. THE CUSTOMER FEEDBACK THAT THE SUTURE BROKE EASILY WHEN IT WAS PULLED SLIGHTLY. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE'S NO REPORT ON PATIENT'S INJURY. THE ACTUAL SAMPLE CANNOT BE RETURNED, BUT THERE WILL BE 21 STERILE SAMPLES FROM SAME LOT TO BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780635 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, 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 IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24733924 ↗
• MalfunctionAug 14, 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. PRIOR TO USE ON THE PATIENT, THE STAFF WAS OPENING FOR A CASE AND OPENED A SUTURE THAT CONTAINED A HAIR UNDERNEATH WITHIN THE TRAY OF THE SUTURE. THEY HAD TO BREAK DOWN THE ENTIRE TABLE AND DISCARD OTHER SUPPLIES OPEN DUE TO THE CONTAMINATION. NO ADVERSE PATIENT EVENTS AS THIS OCCURRED BEFORE THE PROCEDURE STARTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810265 ↗
• MalfunctionAug 14, 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. PRIOR TO USE ON THE PATIENT, THE STAFF WAS OPENING FOR A CASE AND OPENED A SUTURE THAT CONTAINED A HAIR UNDERNEATH WITHIN THE TRAY OF THE SUTURE. THEY HAD TO BREAK DOWN THE ENTIRE TABLE AND DISCARD OTHER SUPPLIES OPEN DUE TO THE CONTAMINATION. NO ADVERSE PATIENT EVENTS AS THIS OCCURRED BEFORE THE PROCEDURE STARTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810263 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ENDOSCOPIC NEUROMICROVASCULAR DECOMPRESSION ON THE RIGHT SIDE ON (B)(6) 2025 AND SUTURE WAS USED. THE SCRUB NURSE FOUND THAT THE TIP OF THE SUTURE NEEDLE WAS MISSING DURING THE SURGERY. THE SURGEON IMMEDIATELY SUSPENDED THE SURGICAL OPERATION FOR SEARCHING AND FOUND THAT IT REMAINED AT THE TIP OF THE NEEDLE HOLDER. THE SEARCHING PROCESS DID NOT EXCEED 10 MINUTES, AND THEN THE SURGICAL OPERATION WAS CONTINUED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532626 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NO NEEDLE TIP. IT WAS REPORTED THAT THERE HAD BEEN NO NEEDLE TIP ON THE NEEDLE OF ONE OF THE SUTURES 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 22520472 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED DURING THE PROCEDURE, THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159073 ↗
• MalfunctionSep 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN THYROID PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PRODUCT WAS FOUND CONTAMINATED AFTER OPENING THE PACKAGE DURING THE SURGERY. 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 20291310 ↗
• MalfunctionSep 16, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE 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. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223222 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LIVER AND GALLBLADDER PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE BROKE DURING SEWING. THEN CT WAS USED TO LOOK FOR THE BROKEN NEEDLE BUT FAILED. THE PATIENT IS CURRENTLY STABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20181538 ↗
• MalfunctionMar 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED WITH HOLE PRIOR TO USE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815676 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT GALLBLADDER SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR GALLBLADDER SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764675 ↗
• MalfunctionOct 31, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN RADICAL RESECTION OF HILAR CHOLANGIOCARCINOMA PROCEDURE ON (B)(6) 2023 AND A SUTURE WAS USED. IT WAS REPORTED THAT THE PRIMARY PACKAGE WAS FOUND DAMAGED PRIOR TO PLANNED USE. CHANGED ANOTHER ONE TO COMPLETE THE RADICAL RESECTION OF HILAR CHOLANGIOCARCINOMA SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040299 ↗
• MalfunctionFeb 13, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED FREE OF THE NEEDLE TOO EASILY AND THE SUTURE WAS FRAYING. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363602 ↗
• MalfunctionFeb 6, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED FREE OF THE NEEDLE TOO EASILY AND THE SUTURE WAS FRAYING. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306076 ↗
• MalfunctionFeb 6, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED FREE OF THE NEEDLE TOO EASILY AND THE SUTURE WAS FRAYING. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306071 ↗
• MalfunctionFeb 6, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED FREE OF THE NEEDLE TOO EASILY AND THE SUTURE WAS FRAYING. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306057 ↗
• MalfunctionDec 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE TIP WAS FOUND TO BE MISSING DURING THE PROCEDURE. IT WAS NOT SURE IF THERE WAS NO NEEDLE TIP OR NEEDLE TIP BREAKAGE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. C-ARM MACHINE AND B ULTRASOUND WERE USED TO FIND THE NEEDLE TIP DURING THE OP, BUT WAS NOT FOUND. THE PROCEDURE WAS EXTENDED APPROXIMATELY 2 HOURS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928959 ↗
• MalfunctionAug 17, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE PRODUCT NUMBERS OF THE BOX PACKAGE AND THE ALUMINUM PACKAGE INSIDE WERE DIFFERENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15243159 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TITLE: COMPOUND RADIX SOPHORAE FLAVESCENTIS LOTION IRRIGATION COMBINED WITH THUNDERBOLT MOXIBUSTION FOR POOR HEALING OF EPISIOTOMY. THIS STUDY AIMS TO EVALUATE THE CLINICAL EFFECT OF COMPOUND KUSHEN LOTION IRRIGATION COMBINED WITH THUNDERBOLT MOXIBUSTION IN THE TREATMENT OF POOR HEALING OF LATERAL EPISIOTOMY FROM JANUARY 2018 TO SEPTEMBER 2019, 125 PARTURIENTS, AVERAGE YEARS THE AGE WAS (24 ± 2.3) YEARS, WITH POOR HEALING OF LATERAL EPISIOTOMY, WHERE 4/0 ABSORBABLE SUTURE (ANTIBACTERIAL VICRYL ABSORBABLE SUTURE, VCP714D JOHNSON & JOHNSON, USA) CONTINUOUS SUTURE) WAS USED, FOR VAGINAL DELIVERY WHO MET THE CRITERIA WERE RANDOMLY DIVIDED INTO THE CONTROL GROUP (N=62) CASES AND THE TEST GROUP (N=63) CASES. REPORTED COMPLICATIONS INCLUDED: (N=125) PARTURIENTS WITH POOR HEALING OF LATERAL EPISIOTOMY. 62 CASES IN THE CONTROL GROUP WAS GIVEN POTASSIUM PERMANGANATE SOLUTION 1:5000 HEATED TO 35-43 SITZ BATH, ONCE A DAY, COMBINED WITH MAGNESIUM SULFATE WET COMPRESS, FAR INFRARED IRRADIATION WILL NEGATIVE FOR 20 MIN. 63 CASES IN THE TEST GROUP WERE GIVEN COMPOUND KUSHEN LOTION (HEATED TO 35-43) THE PERINEUM WAS WASHED ONCE A DAY, COMBINED WITH THUNDERBOLT MOXIBUSTION SUSPENSION MOXIBUSTION FOR

  Patient problems: Impaired Healing; Necrosis; Pain; Purulent Discharge; Skin Inflammation/ Irritation; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 15112324 ↗
• MalfunctionOct 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THE NEEDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611475 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE SEWING EXTERNAL CLOSURE OF SKULL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418016 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE EASILY WHEN PULLED WHILE SEWING THE SURGICAL WOUND. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791790 ↗
• MalfunctionSep 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE BROKE DURING SEWING TISSUE OF THYROID STUMP IN THYROID 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; No Consequences Or Impact To Patient

  MAUDE report 10594083 ↗

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