Coated VICRYL VCP426HRecalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10705031053137), received between Jan 17, 2020 and Sep 29, 2026 — classified as 2 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Material Separation” (58 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936875 ↗
• MalfunctionSep 29, 2026Delivered as Unsterile Product

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. An issue was identified where the needle protruded through the suture packaging and subsequently pierced the adjacent package, resulting in a hole in the neighboring package. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936821 ↗
• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668273 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395997 ↗
• MalfunctionApr 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874323 ↗
• MalfunctionApr 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874307 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE SUTURE DETACHED FROM THE NEEDLE. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859553 ↗
• MalfunctionOct 25, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2024 AND SUTURE WAS USED. AT 9:00 AM, WHEN THE DOCTOR WAS SUTURING THE ABDOMINAL INCISION OF A CESAREAN SECTION MOTHER, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND WERE DISCARDED AND REPLACED WITH NEW SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532951 ↗
• MalfunctionAug 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION+LIGATION SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 16:25, WHILE PERFORMING SURGERY ON A PREGNANT WOMAN AND SUTURING HER ABDOMINAL INCISION, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE INCISION WAS ABOUT 2/3 OF THE DISTANCE. 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 20076002 ↗
• MalfunctionApr 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL CLOSURE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NURSE FOUND THAT THE SUTURE HAD PULLED OFF FROM THE NEEDLE. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059445 ↗
• MalfunctionApr 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES AND THREADS SEPARATED DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046489 ↗
• MalfunctionApr 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES AND THREADS SEPARATED DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046422 ↗
• MalfunctionMar 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON 5-MARCH-2024, AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING THE SKIN, AND THE DOCTOR STOPPED USING THE SUTURE. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977171 ↗
• MalfunctionMar 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924261 ↗
• MalfunctionMar 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924259 ↗
• MalfunctionOct 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENSION-FREE REPAIR OF RIGHT OBLIQUE HERNIA SURGERY ON (B)(4) 2023 AND SUTURE WAS USED. DURING THE TENSION-FREE REPAIR OF RIGHT OBLIQUE HERNIA SURGERY, WHEN THE DOCTOR USED SUTURE TO SEW THE PATIENT'S SKIN, DUE TO INSUFFICIENT TOUGHNESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. 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 18040505 ↗
• MalfunctionJul 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AT 10:30, IT WAS REPORTED THAT THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED WHEN THE SURGEON ATTEMPTED TO SEW THE ABDOMINAL INCISION. 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 17405845 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND A SUTURE WAS USED. AT 15:20, WHEN THE DOCTOR SUTURED THE PATIENT'S ABDOMINAL INCISION, TWO STITCHES WERE JUST SUTURED, AND THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED. REPLACE WITH NEW SUTURE. AFTER REMOVING THE SUTURE, THE INCISION WAS RE-SUTURED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317192 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 16:00, WHEN THE DOCTOR PERFORMED ABDOMINAL INCISION AND SUTURING FOR THE PATIENT, THE SUTURE WAS ALREADY HALFWAY COMPLETED, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED . 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 17066372 ↗
• MalfunctionFeb 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THAT THE NEEDLE POPPED OFF THE SUTURE WITH SKIN CLOSURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453623 ↗
• MalfunctionDec 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE FROM THE NEEDLE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054627 ↗
• MalfunctionSep 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE NEEDLE BROKE FROM THE SUTURE DURING THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15413167 ↗
• MalfunctionAug 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE PULLED OFF THE NEEDLE HAPPENED DURING SEWING ABDOMINAL INCISION IN 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 15197439 ↗
• MalfunctionAug 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 WAS PULLING OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15193377 ↗
• MalfunctionAug 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 WAS PULLING OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15193342 ↗

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