Coated VICRYL J552GRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031041172), received between Jun 26, 2019 and Jan 31, 2024 — classified as 9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE SURGERY ON (B)(6) 2023 AND SURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613533 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE SURGERY ON (B)(6) 2023 AND SURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613532 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE IS BREAKING WHILE IN USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608545 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE IS BREAKING WHILE IN USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608524 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN EYE MUSCLE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS SNAPPING WHILE IN USE, CAUSING A RISK IN PATIENT CARE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607556 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A EYE MUSCLE PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS SNAPPING WHILE IN USE, CAUSING A RISK IN PATIENT CARE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607554 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A EYE MUSCLE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WOULD DISINTEGRATE WHEN THE SURGEON WAS TRYING TO USE FOR MUSCLE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282840 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, BIFURCATION OF THE SUTURE OCCURRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391538 ↗
• MalfunctionJun 26, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE STAFF FOUND THAT THE SUTURE WAS BROKEN BEFORE USE. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, THE SUTURE PIECES WERE EXAMINED AND HAVE BEGUN WITH THE PROCESS OF DEGRADATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736424 ↗

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