Coated VICRYL J386HRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031039490), received between Oct 29, 2020 and May 29, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE WHILE THEY WERE PERFORMING THE PROCEDURE. THE CUSTOMER CONFIRMED THAT THEY HAD USED A BRAND-NEW BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110675 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE WHILE THEY WERE PERFORMING THE PROCEDURE. THE CUSTOMER CONFIRMED THAT THEY HAD USED A BRAND-NEW BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110673 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. THE BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002914 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. THE BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002913 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968303 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968302 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968299 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968296 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968289 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968287 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968285 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968282 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968280 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968278 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968273 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968271 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968264 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968262 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024. MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY, BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968128 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024. MULTIPLE INCIDENTS OCCURRED DURING ORTHOPEDIC SURGERIES AND GS PROCEDURES. BROKEN NEEDLES FELL INTO THE PATIENT'S BODY, BUT WERE ALL TAKEN OUT WITHOUT ANY OBVIOUS NEGATIVE IMPACT. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968126 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675856 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675852 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675851 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAS BEEN BREAKING, THEY HAVE HAD THREE BREAK WITHIN THE LAST TWO DAYS. THEY HAVE USED THIS BRAND FOR THE LAST SEVERAL YEARS WITH NO ISSUES BUT THIS IS OBVIOUSLY A SAFETY CONCERN FOR THEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651843 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAS BEEN BREAKING, THEY HAVE HAD THREE BREAK WITHIN THE LAST TWO DAYS. THEY HAVE USED THIS BRAND FOR THE LAST SEVERAL YEARS WITH NO ISSUES BUT THIS IS OBVIOUSLY A SAFETY CONCERN FOR THEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651842 ↗