Coated VICRYL J839DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031043220), received between Nov 28, 2018 and Jun 14, 2023 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionJun 14, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DIEP FLAP PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE DOING TOP STITCHES, THE SUTURE FRAYED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130184 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE IN 2020 AND THE SUTURE WAS USED. POST-OPERATIVE, THE PATIENT EXPERIENCED WOUND DEHISCENCE AND WAS RE-SUTURED ON (B)(6) 2020. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 10760364 ↗
• MalfunctionDec 3, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS OPENED, HOWEVER THE ITEM INSIDE WAS LABELED AS DIFFERENT PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124684 ↗
• MalfunctionDec 3, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS OPENED, HOWEVER THE ITEM INSIDE WAS LABELED AS DIFFERENT PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124678 ↗
• MalfunctionNov 28, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2018, AND SUTURE WAS USED. WHEN THE BOX OF SUTURE WAS OPENED, IT APPEARED THAT ONE OF THE CONTROL RELEASE PACKAGES WAS SOILED INSIDE THE FOIL PACK AND THAT THE STERILITY OF THE PRODUCT WAS COMPROMISED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111672 ↗

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