Coated VICRYL VCP422H (UDI 10705031149953)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031149953), received between Sep 17, 2024 and Sep 21, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported that the plus suture was breaking in the middle under gentle tension. No delay or patient harm was reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840911 ↗
• MalfunctionSep 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591654 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235529 ↗
• MalfunctionJul 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE WOUND WAS SUTURED DURING THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717171 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY 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 WILL RETURN 36 REPRESENTATIVE SAMPLES FOR ANALYSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055838 ↗
• MalfunctionApr 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. THE PARTURIENT GAVE BIRTH AT 08:38 WITH A FIRST-DEGREE PERINEAL LACERATION. THE PERINEUM BEGAN TO BE SUTURED AT 08:45, AND THE NEEDLE PULL OFF ISSUE HAPPENED DURING THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957292 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CIRCUMCISION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AFTER THE PATIENT'S SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE DOCTOR'S SUTURING PROCESS. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE, WHICH INCREASED THE CONSUMPTION OF CONSUMABLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925990 ↗
• MalfunctionMar 20, 2026Component Misassembled

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 A SUTURE WAS USED. RECEIVED UNDYED SUTURE CODE INSTEAD OF DYED WITH SAME CODE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647891 ↗
• MalfunctionMar 20, 2026Component Misassembled

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 A SUTURE WAS USED. RECEIVED UNDYED SUTURE CODE INSTEAD OF DYED WITH SAME CODE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647890 ↗
• MalfunctionMar 20, 2026Component Misassembled

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 A SUTURE WAS USED. RECEIVED UNDYED SUTURE CODE INSTEAD OF DYED WITH SAME CODE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647889 ↗
• MalfunctionMar 20, 2026Component Misassembled

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 A SUTURE WAS USED. RECEIVED UNDYED SUTURE CODE INSTEAD OF DYED WITH SAME CODE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647886 ↗
• MalfunctionMar 20, 2026Component Misassembled

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 A SUTURE WAS USED. RECEIVED UNDYED SUTURE CODE INSTEAD OF DYED WITH SAME CODE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647884 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS BY THE SURGEON THAT DURING SURGERY, NEEDLE ON SUTURE "BROKE IN HALF" DURING CLOSURE. NEEDLE/SUTURE DISPOSED OF BY STAFF BECAUSE CONTAMINATED AND ALREADY IN NEEDLE TRAY. SURGERY CASE WAS "DIAGNOSIS LAP VENTRAL HERNIA REPAIR LYSIS OF ADHESIONS". THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469138 ↗
• MalfunctionJan 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SEWING DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115969 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE SPLIT DURING THE SUTURING PROCESS. REPLACED IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974441 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PELVIC PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF A PELVIC MASS. ON THE MORNING OF THE SECOND DAY AFTER ADMISSION, DURING THE SURGERY, THE DOCTOR USED SUTURE FOR SUTURING, BUT THE SUTURE SUDDENLY BROKE. THE DOCTOR PROMPTLY REPLACED THE SUTURE AND SUCCESSFULLY COMPLETED THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348370 ↗
• MalfunctionJul 30, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE IS EASILY BROKEN AND NEEDLE IS EASILY BENT DURING SUTURING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663928 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY. 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 22395235 ↗
• MalfunctionApr 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, THE PARTURIENT UNDERWENT SURGERY. DURING THE SURGERY, LACTATED RINGER'S SOLUTION WAS INJECTED INTRAVENOUSLY, HIGH-FREQUENCY ELECTRIC KNIFE WAS USED TO CUT AND COAGULATE BLOOD, AND SUTURE WAS USED TO SUTURE THE SKIN. AFTER THE SURGERY, THE PATIENT RETURNED TO THE WARD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 5 DAYS. THE WOUND WAS FOUND TO BE HEALING WELL AND WAS ALLOWED TO BE DISCHARGED. 23 DAYS AFTER THE SURGERY ON (B)(6) 2025, THE PARTURIENT RETURNED TO THE HOSPITAL AND COMPLAINED OF WOUND EXUDATION. AFTER CHECKING, THE SUTURE WAS FOUND TO BE EXPOSED. THE DOCTOR USED STERILE FORCEPS TO CLAMP THE THREAD END AND FOUND THAT THE SUTURE WAS NOT ABSORBED. THE WOUND DRESSING WAS CHANGED IMMEDIATELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing; Pocket Erosion

  MAUDE report 21936125 ↗
• MalfunctionApr 30, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, HE PARTURIENT UNDERWENT SURGERY. DURING THE SURGERY, LACTATED RINGER'S SOLUTION WAS INJECTED INTRAVENOUSLY, HIGH-FREQUENCY ELECTRIC KNIFE WAS USED TO CUT AND COAGULATE BLOOD, AND SUTURE WAS USED TO SUTURE THE SKIN. AFTER THE SURGERY, THE PATIENT RETURNED TO THE WARD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 4 DAYS LATER. THE WOUND WAS FOUND TO BE HEALING WELL AND WAS ALLOWED TO BE DISCHARGED. 37 DAYS AFTER THE SURGERY ON (B)(6) 2025, THE PARTURIENT RETURNED TO THE HOSPITAL AND COMPLAINED OF WOUND EXUDATION. AFTER CHECKING, THE SUTURE WAS FOUND TO BE EXPOSED. THE DOCTOR USED STERILE FORCEPS TO CLAMP THE THREAD END AND FOUND THAT THE SUTURE WAS NOT ABSORBED. THE WOUND DRESSING WAS CHANGED IMMEDIATELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 21935717 ↗
• MalfunctionMar 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING 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 21732623 ↗
• MalfunctionMar 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING 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 21732302 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AT ABOUT 10:00 A.M., THE DOCTOR WAS USING SUTURE TO SUTURE THE SKIN DURING THE SURGERY, BUT THE NEEDLE SUDDENLY BROKE, SO THE DOCTOR STOPPED USING IT AND CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242258 ↗