Coated VICRYL J464GRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031040151), received between Mar 9, 2020 and Jul 28, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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.

• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. 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 22637630 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SUTURES BREAKING. IT IS UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209880 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SUTURES BREAKING. IT IS UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209879 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SUTURES BREAKING. IT IS UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209877 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SUTURES BREAKING. IT IS UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209672 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SUTURES BREAKING. IT IS UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209670 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SUTURES BREAKING. IT IS UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209661 ↗
• MalfunctionMay 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CYST EXCISION ON (B)(6) 2022 AND SUTURE WAS USED. THREE OUT OF SIX SUTURES USED SO FAR HAVE BROKEN-THE NEEDLE CAME OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349620 ↗
• MalfunctionMay 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN BASAL CELL CARCINOMA REMOVAL ON (B)(6) 2022 DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT THE SUTURES HAVE BROKEN-THE NEEDLE CAME OFF. TWO SUTURES WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345893 ↗
• MalfunctionMay 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN BASAL CELL CARCINOMA REMOVAL ON (B)(6) 2022 DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT THE SUTURES HAVE BROKEN-THE NEEDLE CAME OFF. TWO SUTURES WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345892 ↗
• MalfunctionMay 7, 2022Material Separation; Material Separation

  IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE NEEDLE CAME OFF. SAMPLES ARE AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14318232 ↗
• MalfunctionMay 7, 2022Material Separation; Material Separation

  IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE NEEDLE CAME OFF. SAMPLES ARE AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14318104 ↗
• MalfunctionMay 7, 2022Material Separation; Material Separation

  IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE NEEDLE CAME OFF. SAMPLES ARE AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317999 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERONEAL LACERATION PROCEDURE POST VAGINAL DELIVERY AND SUTURE WAS USED. THE NEEDLE BROKE DURING THE HERNIA REPAIR POST-DELIVERY. THE PATIENT WAS SENT FOR X-RAY, BUT THE NEEDLE WAS NOT FOUND. THE PATIENT RECOVERED NORMALLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11013682 ↗
• InjuryMar 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REPAIR OF LIP LACERATION AFTER A DOG BITE ON (B)(6) 2019 AND SUTURE WAS USED. WHILE SUTURING MUSSEL TISSUE THE SUTURE WAS USED AND AS IT WAS PASSED THROUGH TISSUE THE NEEDLE POPPED OFF OF THE SUTURE AND EMBEDDED IN THE PATIENTS LIP. THE PATIENT WAS SENT TO A PLASTIC SURGEON TO REMOVE THE NEEDLE AND ADDRESS THE PATIENT LIP. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9808650 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc