Coated VICRYL J808TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031043077), received between Sep 23, 2020 and Dec 29, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K022269, K183183); 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.

• MalfunctionDec 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11092173 ↗
• MalfunctionSep 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A HORSE UNDERWENT A COLIC PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED ON THE ABDOMEN. DURING THE PROCEDURE, THE SUTURE PULLED OFF COMPLETELY AT THE SWAGE PART OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574903 ↗
• MalfunctionSep 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A HORSE UNDERWENT A COLIC PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED ON THE ABDOMEN. DURING THE PROCEDURE, THE SUTURE PULLED OFF COMPLETELY AT THE SWAGE PART OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574900 ↗
• MalfunctionSep 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A HORSE UNDERWENT A COLIC PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED ON THE ABDOMEN. DURING THE PROCEDURE, THE SUTURE PULLED OFF COMPLETELY AT THE SWAGE PART OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574891 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
• 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