Coated VICRYL VCP468HRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031053519), received between Aug 26, 2022 and Sep 5, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22981229 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868726 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868722 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866565 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864960 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864898 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864881 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864857 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864826 ↗
• MalfunctionAug 21, 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 SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE FIRST CASE OCCURRED WHEN USED IN A TOTAL HIP ARTHROPLASTY, AND THE SECOND CASE OCCURRED WHEN A DIFFERENT DOCTOR USED ON THE ARTIFICIAL FEMORAL HEAD. THIS OCCURRED IN 70-80% OF APPROXIMATELY 10 PRODUCTS. THE INCIDENCE RATE IS HIGH AND THERE ARE SAFETY CONCERNS, THE CUSTOMER WOULD LIKE TO EXCHANGE WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864700 ↗
• MalfunctionSep 13, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410659 ↗
• MalfunctionAug 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE SUTURE MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306572 ↗
• MalfunctionAug 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE SUTURE MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306531 ↗
• MalfunctionAug 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE SUTURE MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306520 ↗
• MalfunctionAug 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE SUTURE MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306475 ↗

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