Coated VICRYL J452HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031040014), received between May 14, 2018 and Mar 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DELIVERY PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. DURING THE PROCESS OF ASSISTING THE PATIENT WITH CHILDBIRTH, THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED WHILE SUTURING THE PERINEAL INCISION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621364 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE AT THE END OF THE NEEDLE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905082 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THE PATIENT BECAME PREGNANT FOUR TIMES, GAVE BIRTH ONCE, AND WAS 39 WEEKS PREGNANT WITH HEAD POSITION. AFTER IVF-ET SURGERY. ELDERLY PARTURIENTS. AT 8:50 IN THE MORNING, DURING THE SURGERY, THE DOCTOR SUTURED THE SKIN AND THE MIDDLE SECTION OF THE SUTURE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703804 ↗
• MalfunctionJul 3, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED FELINE ANIMAL PROCEDURE, SUTURE WAS USED. AFTER THE PROCEDURE THE SUTURE HAS ABSORPTION ISSUES. IT WAS UNKNOWN HOW LONG AFTER THE PROCEDURE THIS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661574 ↗
• MalfunctionJun 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED FELINE ANIMAL PROCEDURE, SUTURE WAS USED. AFTER THE PROCEDURE THE SUTURE HAS ABSORPTION ISSUES. IT WAS UNKNOWN HOW LONG AFTER THE PROCEDURE THIS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7610912 ↗
• MalfunctionJun 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED FELINE ANIMAL PROCEDURE, SUTURE WAS USED. AFTER THE PROCEDURE THE SUTURE HAS ABSORPTION ISSUES. IT WAS UNKNOWN HOW LONG AFTER THE PROCEDURE THIS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7610519 ↗
• MalfunctionMay 14, 2018Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A FELINE UNDERWENT A SURGICAL PROCEDURE ON 03/14/2018 AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE ¿SUTURES PULLED OUT¿. IT WAS UNKNOWN HOW LONG AFTER THE PROCEDURE THIS OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED FOR CLARIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7511569 ↗