Coated VICRYL J453HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031040021), received between Jun 17, 2019 and Jan 29, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THE SUTURE IS COMING OFF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263173 ↗
• MalfunctionJan 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THE SUTURE IS COMING OFF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139417 ↗
• MalfunctionDec 17, 2024Break; Material Separation; Material Twisted/Bent; Break; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING THAT THE SUTURE IS BREAKING AT TIMES ALONG WITH THE NEEDLES POPPING OFF AND BENDING WHEN PASSING THROUGH. THEY HAD TO KEEP USING MORE UNTIL IT WORKED TO COMPLETE THE CASE. NEEDLES DID NOT FALL INTO THE PATIENT AND THERE WAS NO PATIENT HARM REPORTED.. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20951474 ↗
• MalfunctionDec 17, 2024Break; Material Separation; Material Twisted/Bent; Break; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING THAT THE SUTURE IS BREAKING AT TIMES ALONG WITH THE NEEDLES POPPING OFF AND BENDING WHEN PASSING THROUGH. THEY HAD TO KEEP USING MORE UNTIL IT WORKED TO COMPLETE THE CASE. NEEDLES DID NOT FALL INTO THE PATIENT AND THERE WAS NO PATIENT HARM REPORTED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20951466 ↗
• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON 30-OCT-2023 AND SUTURE WAS USED. THE NEEDLE BROKE OFF WHEN SUTURING INSIDE THE PET. THE PROCEDURE WAS EXTENDED BY AN UNKNOWN LENGTH OF TIME. THERE WERE NO ADVERSE CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248458 ↗
• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON 30-OCT-2023 AND SUTURE WAS USED. THE NEEDLE BROKE OFF WHEN SUTURING INSIDE THE PET. THE PROCEDURE WAS EXTENDED BY AN UNKNOWN LENGTH OF TIME. THERE WERE NO ADVERSE CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248431 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE VETERINARIAN WAS TYING OFF PEDICLES, THE VETERINARIAN COULDN'T APPLY TENSION TO THE SUTURE WITHOUT THE SUTURE BREAKING. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SUTURE. THERE WERE NO CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704063 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE VETERINARIAN WAS TYING OFF PEDICLES, THE VETERINARIAN COULDN'T APPLY TENSION TO THE SUTURE WITHOUT THE SUTURE BREAKING. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SUTURE. THERE WERE NO CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704061 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE VETERINARIAN WAS TYING OFF PEDICLES, THE VETERINARIAN COULDN'T APPLY TENSION TO THE SUTURE WITHOUT THE SUTURE BREAKING. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SUTURE. THERE WERE NO CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704060 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE VETERINARIAN WAS TYING OFF PEDICLES, THE VETERINARIAN COULDN'T APPLY TENSION TO THE SUTURE WITHOUT THE SUTURE BREAKING. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SUTURE. THERE WERE NO CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704059 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE VETERINARIAN WAS TYING OFF PEDICLES, THE VETERINARIAN COULDN'T APPLY TENSION TO THE SUTURE WITHOUT THE SUTURE BREAKING. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SUTURE. THERE WERE NO CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704057 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE VETERINARIAN WAS TYING OFF PEDICLES, THE VETERINARIAN COULDN'T APPLY TENSION TO THE SUTURE WITHOUT THE SUTURE BREAKING. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SUTURE. THERE WERE NO CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704053 ↗