Coated VICRYL JB946Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031044074), received between Aug 13, 2018 and Aug 3, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 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.

• MalfunctionAug 3, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THERE WAS A FOREIGN SUBSTANCE LIKE A HAIR IN THE STERILE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15159290 ↗
• InjuryAug 13, 2018Break; Break

  IT WAS REPORTED VIA VOLUNTARY FACILITY MW (B)(4) THAT THE PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED UTERINE DEHISCENCE AND BROKEN SUTURE. THE PATIENT WAS SEEN FOR EVALUATION OF INCISIONAL BLEEDING. THE PATIENT WAS BROUGHT TO THE BED AND INCISION WAS EVALUATED. STERI-STRIPS WERE REMOVED AND TISSUE EXTRUDING FROM PATIENT'S INCISION WAS CONSISTENT WITH FALLOPIAN TUBE. AT THIS POINT, INCISIONAL DEHISCENCE WAS CALLED AND THE OPERATING ROOM TEAM WAS CALLED IN FOR EMERGENT SURGERY. THE PHYSICIAN OPINED COMPLETE FASCIAL DEHISCENCE WITH EVIDENCE OF SUTURE TEAR MIDLINE THROUGH THE ABDOMINAL INCISION, THE KNOTS WERE INTACT AND FASCIA AND REMAINDER OF TISSUE NORMAL. THE PHYSICIAN OPINED NO OTHER SUTURES WERE NOTED TO BE TORN UPON EXPLORATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blood Loss; Not Applicable; Wound Dehiscence

  MAUDE report 7776949 ↗

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