Coated VICRYL J714DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031042483), received between Oct 28, 2019 and Jan 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 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 AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE NEEDLE TIP WAS CHIPPED IN THE MIDDLE OF THE SURGERY. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. IT IS UNKNOWN WHETHER NEEDLE PIECE FELL INTO THE SURGICAL FIELD AND WHETHER NEEDLE PIECE WAS SEARCHED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220433 ↗
• MalfunctionFeb 1, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276884 ↗
• MalfunctionDec 14, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE WHEN TRYING TO DETACH THE NEEDLE FROM THE SUTURE, THE NEEDLE TIP WAS BROKEN, AND IT FELL ON THE SURGICAL FIELD. THE BROKEN NEEDLE AND NEEDLE TIP HAVE BEEN RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003577 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AND WAS NOT USED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238907 ↗
• MalfunctionApr 22, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A HAIR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985719 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL EXCISIONAL BIOPSY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE IN HALF WHILE ATTEMPTING TO SUTURE DEEP DERMAL TISSUE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. BOTH THE BROKEN NEEDLE AND THE SWAGED NEEDLE WERE RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247185 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL EXCISIONAL BIOPSY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE IN HALF WHILE ATTEMPTING TO SUTURE DEEP DERMAL TISSUE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. BOTH THE BROKEN NEEDLE AND THE SWAGED NEEDLE WERE RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247171 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL EXCISIONAL BIOPSY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE IN HALF WHILE ATTEMPTING TO SUTURE DEEP DERMAL TISSUE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. BOTH THE BROKEN NEEDLE AND THE SWAGED NEEDLE WERE RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247168 ↗