Coated VICRYL VCP460H (UDI 10705031053410)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705031053410), received between Jan 25, 2018 and Feb 26, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Break; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHEN THE SUTURE WAS TAKEN OUT DURING USE, IT WAS SLIGHTLY FRAYED, AND WHEN IT WAS USED, THAT PART WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457855 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, , THE SUTURE WAS DETACHED FROM THE NEEDLE, AND THIS HAPPENED IN 3 PACKAGES. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946623 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, , THE SUTURE WAS DETACHED FROM THE NEEDLE, AND THIS HAPPENED IN 3 PACKAGES. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946622 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, , THE SUTURE WAS DETACHED FROM THE NEEDLE, AND THIS HAPPENED IN 3 PACKAGES. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946621 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHING FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING DURING THE SURGERY. THE PRODUCT WAS USED ON THE SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744919 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHING FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING DURING THE SURGERY. THE PRODUCT WAS USED ON THE SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744916 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHING FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING DURING THE SURGERY. THE PRODUCT WAS USED ON THE SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744910 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHING FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING DURING THE SURGERY. THE PRODUCT WAS USED ON THE SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744897 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHING FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING DURING THE SURGERY. THE PRODUCT WAS USED ON THE SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744881 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHING FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING DURING THE SURGERY. THE PRODUCT WAS USED ON THE SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744877 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHING FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING DURING THE SURGERY. THE PRODUCT WAS USED ON THE SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744872 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHING FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING DURING THE SURGERY. THE PRODUCT WAS USED ON THE SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744862 ↗
• MalfunctionSep 12, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED A PATIENT UNDERWENT A WOUND CLOSURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE BROKE DURING THE TRAUMA SUTURING PROCESS . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732599 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE AND THIS HAPPENED IN 2 PRODUCTS IN A ROW. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLES TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651490 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE AND THIS HAPPENED IN 2 PRODUCTS IN A ROW. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLES TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651449 ↗
• MalfunctionAug 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING SUTURING. BECAUSE THE SUTURE WAS DETACHED FROM THE NEEDLE WHILE THE SURGEON HELD THE NEEDLE, THE SURGEON KNEW THE EXACT WHERE THE NEEDLE WAS. THIS HAPPENED IN 2 PRODUCTS IN A ROW. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583489 ↗
• MalfunctionAug 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING SUTURING. BECAUSE THE SUTURE WAS DETACHED FROM THE NEEDLE WHILE THE SURGEON HELD THE NEEDLE, THE SURGEON KNEW THE EXACT WHERE THE NEEDLE WAS. THIS HAPPENED IN 2 PRODUCTS IN A ROW. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583487 ↗
• MalfunctionAug 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER OPENING THE PACKAGE AND BEFORE USE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547373 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PLANNED CAESAREAN SECTION ON (B)(6) 2021 AND SUTURE WAS USED. WHILE THE SURGEON WAS SUTURING THE UTERINE BREACH, THE NEEDLE BROKE. TO RECOVER THE MISSING PART OF THE NEEDLE, THE UTERINE BREACH HAD TO BE REOPENED AND RESUTURED WITH A NEW THREAD AND NEEDLE. THE NEEDLE WAS RETRIEVED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314697 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARRHYTHMIA SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. WHEN TYING THE SUTURE DURING CONTINUOUS SUTURING, THE WEAVING OF THE SUTURE WAS TORN EXCEPT FOR CENTER SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314693 ↗
• MalfunctionJun 5, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE AT THE TIP WHEN SEWING DURING THE PROCEDURE. THE NEEDLE TIP WASN'T FOUND. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10124018 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN EASILY THOUGH IT WAS STILL WITHIN THE STERILITY VALIDITY PERIOD. THE REST OF STERILIZATION PERIOD WAS 1 MONTH AT THAT TIME. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON RECEIPT AND EVALUATION: A SECOND SAMPLE WAS RETURNED FOR ANALYSIS AND BREAKAGE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9616608 ↗
• MalfunctionDec 4, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN EASILY THOUGH IT WAS STILL WITHIN THE STERILITY VALIDITY PERIOD. THE REST OF STERILIZATION PERIOD WAS 1 MONTH AT THAT TIME. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411504 ↗
• MalfunctionDec 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE SLIGHTLY AFTER PUTTING THE FIRST STITCH, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402661 ↗
• MalfunctionDec 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE SLIGHTLY AFTER PUTTING THE FIRST STITCH, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402660 ↗

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