Coated VICRYL J504GRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031040731), received between Dec 28, 2023 and Nov 26, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN OPHTHALMOLOGY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING PROCEDURE, THERE WAS AN INCIDENT WITH A SUTURE. WHEN USING THE SUTURE, THE NEEDLE BROKE INTO 2 PIECES. THE PIECE NOT ATTACHED TO THE WIRE FELL INTO THE PATIENT'S EYE. SURGEON HAD TO MAKE A DEEPER INCISION TO RETRIEVE THE PIECE. THE PIECE WAS RECOVERED, THE SURGEON WAS ABLE TO COMPLETE THE OPERATION. FORTUNATELY, THE PATIENT SHOULD NOT HAVE ANY SIDE-EFFECTS FROM THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784703 ↗
• MalfunctionDec 29, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416497 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415846 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410300 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410298 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410294 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410293 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410291 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410288 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410284 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410281 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410278 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410271 ↗
• MalfunctionDec 28, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410262 ↗

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