Coated VICRYL J635HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031041875), received between Apr 1, 2021 and Apr 1, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Integrity 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED TO PERFORM UTERINE COMPRESSION DUE TO HEMOSTASIS. TWO YEARS FOLLOWING THE PROCEDURE, THE PATIENT UNDERWENT FERTILITY TREATMENT AND SUTURE WAS FOUND TO STILL BE IN THE UTERUS. THE PATIENT HAD NO SYMPTOMS. THE SUTURE WAS RETRIEVED DURING LAPAROSCOPY CLIPPING FOR HYDROSALPINGES. IT WAS FURTHER REPORTED THAT WHEN CHECKING THE RETRIEVED SUTURE, THE SUTURE SEEMED NOT BRAIDED, BUT MONOFILAMENT AND BLACK IN COLOR. THE PATIENT HAS RECOVERED AND FERTILITY TREATMENT COULD BE RESUMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11603529 ↗
• InjuryApr 1, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) AND SUTURE WAS USED TO PERFORM UTERINE COMPRESSION DUE TO HEMOSTASIS. TWO YEARS FOLLOWING THE PROCEDURE, THE PATIENT UNDERWENT FERTILITY TREATMENT AND SUTURE WAS FOUND TO STILL BE IN THE UTERUS. THE PATIENT HAD NO SYMPTOMS. THE SUTURE WAS RETRIEVED DURING LAPAROSCOPY CLIPPING FOR HYDROSALPINGES. IT WAS FURTHER REPORTED THAT WHEN CHECKING THE RETRIEVED SUTURE, THE SUTURE SEEMED NOT BRAIDED, BUT MONOFILAMENT AND BLACK IN COLOR. THE PATIENT HAS RECOVERED AND FERTILITY TREATMENT COULD BE RESUMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11603528 ↗

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