Coated VICRYL V549GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031051294), received between Feb 17, 2021 and Apr 6, 2022 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON 03/03/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS CLOSING THE EYELID AND PULLED IT THROUGH TO TIGHTENED AND IT BROKE OFF TWO DIFFERENT TIMES. A THIRD SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021803 ↗
• MalfunctionApr 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON 03/03/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS CLOSING THE EYELID AND PULLED IT THROUGH TO TIGHTENED AND IT BROKE OFF TWO DIFFERENT TIMES. A THIRD SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021799 ↗
• MalfunctionFeb 17, 2021Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339906 ↗

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