Coated VICRYL J352HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031039186), received between May 18, 2018 and Oct 21, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10713049 ↗
• MalfunctionMay 16, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE IN THE CAVITY DURING THE SURGICAL PROCEDURE. IT WAS NECESSARY TO USE AN IMAGE INTENSIFIER TO RETRIEVE THE PIECE THAT BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8618450 ↗
• MalfunctionMay 18, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT HYSTERECTOMY PROCEDURE ON UNKNOWN DATE IN 2018 AND SUTURE WAS USED. A VERY SMALL TIP OF THE NEEDLE BROKE OFF THE NEEDLE WHEN PASSED THROUGH TISSUE. THE TIP OF THE NEEDLE COULD NOT BE RETRIEVED AND X-RAY CONFIRMED THE TIP IS IN THE VAGINAL CUFF. THE SURGEON HAS ELECTED NOT TO REMOVE THE SMALL NEEDLE TIP AND PATIENT IS ASYMPTOMATIC. THE PATIENT WILL BE FOLLOWED ANNUALLY WITH ULTRASOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7526391 ↗