Coated VICRYL J329HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031038875), received between Apr 11, 2019 and Jan 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, 2 SUTURE NEEDLES BROKE UPON ABDOMINAL CLOSING AND CAUSED 15 MINUTE DELAY REQUIRING XRAY TO BE CALLED IN. SUTURE FRAGMENTS WERE RECOVERED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223608 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, 2 SUTURE NEEDLES BROKE UPON ABDOMINAL CLOSING AND CAUSED 15 MINUTE DELAY REQUIRING XRAY TO BE CALLED IN. SUTURE FRAGMENTS WERE RECOVERED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223604 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE BREAKAGE AT THE JUNCTION OF THE THREAD AND THE NEEDLE DURING USE. NEEDLE FELL INTO THE SURGICAL SITE, NEEDLE RECOVERED BY THE SURGEON. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026985 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER DIAGNOSTIC ARTHROSCOPY, AND OPEN REPAIR OF ACUTE MASSIVE ROTATOR CUFF TEAR PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. DURING A SURGICAL PROCEDURE, THE TIP OF SUTURE NEEDLE BROKE OFF.' STAFF ARE UNSURE WHY THIS HAPPENED AND IF ITS DUE TO FAULTY EQUIPMENT OR THE SURGEON USING TOO MUCH FORCE. THE BROKEN BIT WAS NOT LEFT IN THE INCISION BUT REMOVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437920 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. RETRIEVED PIECE FROM PATIENT. REPORTING TODAY AS SEPARATE EVENT AS I REPORTED BOTH INCIDENTS UNDER ONE OCCURRENCE. FIRST REPORT WAS GENERATED ON DATE INFORMATION WAS RECEIVED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265981 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. RETRIEVED PIECE FROM PATIENT. REPORTING TODAY AS SEPARATE EVENT AS I REPORTED BOTH INCIDENTS UNDER ONE OCCURRENCE. FIRST REPORT WAS GENERATED ON DATE INFORMATION WAS RECEIVED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265968 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE. A DELAY IN PROCEDURE WAS REQUIRED SINCE AN X-RAY WAS TAKEN TO LOCATE AND RETRIEVE THE SUTURE. NEW PRODUCT WAS OPENED. NO CONSEQUENCE TO PATIENT OUTCOME POST-SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19621213 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE. A DELAY IN PROCEDURE WAS REQUIRED SINCE AN X-RAY WAS TAKEN TO LOCATE AND RETRIEVE THE SUTURE. NEW PRODUCT WAS OPENED. NO CONSEQUENCE TO PATIENT OUTCOME POST-SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621212 ↗
• MalfunctionApr 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE IN HALF WHEN CLOSING THE INCISION. THE BROKEN PIECE WAS FOUND, AND THE PROCEDURE WAS NOT DELAYED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506082 ↗