Coated VICRYL VCP443H (UDI 10705031053311)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031053311), received between Jun 23, 2020 and Jul 6, 2026 — classified as 10 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN GYNAECOLOGICAL PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING USE, THE SURGEON NOTICED A MISSING CUTTING TIP POINT. AT THIS STAGE, THEY ARE UNSURE WHETHER THE TIP BROKE OFF DURING USE ON THE PATIENT OR WHETHER THE NEEDLE WAS DEFECTIVE AND BLUNT PRIOR TO USE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728404 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR ENCOUNTERS BREAKAGE PROBLEMS VERY REGULARLY ON THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867006 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR ENCOUNTERS BREAKAGE PROBLEMS VERY REGULARLY ON THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866938 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A SUPERFICIAL WOUND PROBLEM WITH REACTIVE CHANGES AROUND THE SUTURE. THE PATIENT HAD TO BE TAKEN BACK TO DEBRIDE THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16336385 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A SUPERFICIAL WOUND PROBLEM WITH REACTIVE CHANGES AROUND THE SUTURE. THE PATIENT WENT ON TO DEVELOP A FORMAL INFECTION. THE PATIENT HAD TO BE TAKEN BACK TO DEBRIDE THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16336070 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A SUPERFICIAL WOUND PROBLEM WITH REACTIVE CHANGE AROUND THE SUTURE. THE PATIENT HAD A VERY NOTABLE PUNCTATE REACTIVE CHANGES AT EVERY SUTURE. THE PATIENT HAD TO BE TAKEN BACK TO DEBRIDE THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16336063 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON HAS BEEN USING THIS SUTURE FOR MANY YEARS WITHOUT PROBLEMS. THE PATIENT EXPERIENCED COMPLICATIONS AND A WOUND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 16294108 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD A SUPERFICIAL SKIN REACTION TO THE SUTURE. THE PATIENT REQUIRED READMISSION AND ADDITIONAL PROCEDURE OF IRRIGATION AND DEBRIDEMENT OF THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 16194731 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON HAS BEEN USING THIS SUTURE FOR MANY YEARS WITHOUT PROBLEMS. THE PATIENT EXPERIENCED COMPLICATIONS AND A WOUND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15907086 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON HAS BEEN USING THIS SUTURE FOR MANY YEARS WITHOUT PROBLEMS. THE PATIENT EXPERIENCED COMPLICATIONS AND A WOUND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15906635 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON HAS BEEN USING THIS SUTURE FOR MANY YEARS WITHOUT PROBLEMS. THE PATIENT EXPERIENED COMPLICATIONS AND A WOUND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15906607 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON HAS BEEN USING THIS SUTURE FOR MANY YEARS WITHOUT PROBLEMS. THE PATIENT EXPERIENCED COMPLICATIONS AND A WOUND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15906525 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ABDOMINAL CLOSURE ON (B)(6) 2022. ON (B)(6) 2022, ON THE 23RD DAY AFTER THE SURGERY, THE PATIENT COMPLAINED OF POOR WOUND HEALING AND CAME TO THE HOSPITAL FOR TREATMENT. AFTER COMING TO THE HOSPITAL, THE DOCTOR CHECKED THE ABDOMINAL WOUND AND FOUND THAT THE PURULENT CHANGES AT THE NEEDLE EYE OF THE WOUND ,AND IT SEEMED THAT THE SUTURE KNOT WAS REJECTED. A SUTURE WAS PULLED OUT IN THE MIDDLE OF THE ABDOMINAL WOUND. ONE MONTH AFTER SURGERY AND ON THE 38TH DAY AFTER SURGERY, THE PATIENT CAME TO THE HOSPITAL FOR EXAMINATION AND FOUND POOR WOUND HEALING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction; Impaired Healing; Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 15130321 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE PULL-OFF DURING TISSUE PASSAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083756 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE PULL-OFF DURING TISSUE PASSAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083742 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE PULL-OFF DURING TISSUE PASSAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083734 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE PULL-OFF DURING TISSUE PASSAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083713 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE PULL-OFF DURING TISSUE PASSAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083711 ↗
• MalfunctionMar 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943061 ↗
• MalfunctionMar 3, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE BROKE AND THE NEEDLE PULLED OFF FROM THE THREAD. THE NEEDLE FELL INSIDE THE PATIENT AND THE SURGEON WAS ABLE TO RETRIEVE IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664713 ↗
• MalfunctionFeb 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY IN (B)(6) OF 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588509 ↗
• MalfunctionFeb 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY IN (B)(6) OF 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588493 ↗
• MalfunctionFeb 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578224 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY AND BREAST AUGMENTATION PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543791 ↗
• MalfunctionFeb 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE DETACHED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502478 ↗

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