Coated VICRYL J415HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031039643), received between Mar 12, 2018 and Nov 24, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THREE SEPARATE OCCASIONS, THE NEEDLE TIP BROKE OFF DURING SKIN CLOSURE ((B)(4), (B)(4) AND (B)(4)). ON A SEPARATE OCCASION, THE SUTURE DETACHED FROM THE NEEDLE. THE DETACHMENT OF THE NEEDLE WAS ALSO DURING KNOT TYING. THERE WAS NO INJURIES OR ADVERSE EVENT TO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631827 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THIS SUTURE HAS HAD THE TIP BREAK OFF RECENTLY IN 3 DIFFERENT CASES. THERE WAS NO INJURIES OR ADVERSE EVENT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524254 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THIS SUTURE HAS HAD THE TIP BREAK OFF RECENTLY IN 3 DIFFERENT CASES. THERE WAS NO INJURIES OR ADVERSE EVENT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524253 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THIS SUTURE HAS HAD THE TIP BREAK OFF RECENTLY IN 3 DIFFERENT CASES. THERE WAS NO INJURIES OR ADVERSE EVENT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524251 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF IN THE SKIN WHILE SUTURING THE PERINEUM CLOSED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580320 ↗
• MalfunctionJun 29, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE SLID OFF THE NEEDLE DURING A REPAIR. PATIENT WAS SUTURED WITH DIFFERENT SUTURES WITHOUT ANY CONCERNS. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851781 ↗
• MalfunctionJun 29, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE SLID OFF THE NEEDLE DURING A REPAIR. PATIENT WAS SUTURED WITH DIFFERENT SUTURES WITHOUT ANY CONCERNS. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851768 ↗
• MalfunctionMar 12, 2018Break; Detachment Of Device Component

  WHILE PERFORMING A VAGINAL REPAIR OF A FOUR DEGREE LACERATION, THE TIP OF THE SUTURE NEEDLE BROKE OFF, REMAINING IN THE PATIENTS TISSUE. NEEDLE WAS LOCATED BY X-RAY AND HAD TO BE SURGICALLY REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque; Laceration(s)

  MAUDE report 7330198 ↗

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