Coated VICRYL J324HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 17891338030407), received between Jun 15, 2022 and Apr 24, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, USING THREADS DURING A BRICKER. THE NEEDLE BROKE AND THE SHARP TIP REMAINED IN THE PATIENT. THE THREAD AND THE REMAINDER OF THE NEEDLE WERE RECOVERED. IMAGE INTENSIFIER IMAGES HAVE BEEN TAKEN AND PLACED IN THE PATIENT FOLDER. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904026 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROTOMY (LEFT NEPHRECTOMY) PROCEDURE ON (B)(6) 2024 AND A SUTURE DEVICE WAS USED. THE DEVICE HAD BROKEN DURING CLOSURE OF THE APONEUROSIS IN A PATIENT OPERATED ON BY LAPAROTOMY (LEFT NEPHRECTOMY) NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645677 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THROAT SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A REACTION TO THE SUTURE IN THE FORM OF INFECTION (PUS). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Purulent Discharge; Unspecified Infection

  MAUDE report 19003083 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THROAT SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A REACTION TO THE SUTURE IN THE FORM OF INFECTION (PUS). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Purulent Discharge; Unspecified Infection

  MAUDE report 19003082 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE IN MAY 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN GYNECOLOGIC SURGERY, THE NEEDLE BROKE AT THE TIP OF 1 - 2 MM AND FELL INTO THE BODY CAVITY AND IT COULD NOT BE FOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14705874 ↗