Coated VICRYL J845GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031043282), received between Aug 10, 2022 and Feb 5, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTOPLASTY FESS ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER PRICKING THE SEPTUM, THE NEEDLE CAME OUT WITHOUT THE POINT. THE SURGEON PERFORMED A GOOD WASH ON THE PATIENT. AFTER THE WASH WAS DONE, THE SUCTION LINER WAS CHECKED AND THE TIP WAS NOT FOUND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE ARE PLANS FOR THE PATIENT TO UNDERGO ANOTHER PROCEDURE WITHIN THE WEEK TO REMOVE THE NEEDLE TIP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18641703 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PRODUCT WAS DEFECTIVE, THE NEEDLE SEPARATED FROM THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318260 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PRODUCT WAS DEFECTIVE, THE NEEDLE SEPARATED FROM THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318256 ↗
• MalfunctionAug 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN HALF. BOTH PIECES OF THE NEEDLE WERE RETRIEVED WITHOUT FURTHER ISSUE. THE CLINICAL TEAM INSPECTED ANOTHER SUTURE FROM THE SAME LOT TO ENSURE IT DIDN'T SNAP. THEY DIDN'T FIND ANY ISSUE WITH THE SECOND NEEDLE. THE PROCEDURE WAS COMPLETED WITH A NEW SUTURE WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198529 ↗

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