Coated VICRYL J474HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031040298), received between Jun 17, 2019 and Jun 27, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD DETACHES ITSELF FROM THE NEEDLE. THE PROBLEM WAS ENCOUNTERED ON TWO WIRES OF THE SAME LOT. THIS PROBLEM HAD ALREADY BEEN NOTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346936 ↗
• MalfunctionJun 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD DETACHES ITSELF FROM THE NEEDLE. THE PROBLEM WAS ENCOUNTERED ON TWO WIRES OF THE SAME LOT. THIS PROBLEM HAD ALREADY BEEN NOTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346935 ↗
• MalfunctionJun 27, 2025Material Separation; Appropriate Device Problem Term/Code Not Available; Material Separation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD DETACHES ITSELF FROM THE NEEDLE. THE PROBLEM WAS ENCOUNTERED ON TWO WIRES OF THE SAME LOT. THIS PROBLEM HAD ALREADY BEEN NOTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346933 ↗
• MalfunctionApr 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THREE SUTURES LOOSENED DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164523 ↗
• MalfunctionApr 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THREE SUTURES LOOSENED DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164511 ↗
• MalfunctionApr 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THREE SUTURES LOOSENED DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164503 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON 10/16/2023 AND SUTURE WAS USED. DURING THE PROCEDURE THE DEVICE BROKE WHEN TYING THE KNOT. TO REPLACE THIS THREAD, ANOTHER WAS USED FROM ANOTHER LOT WAS USED, WHICH SEPARATED FROM ITS NEEDLE WHEN STITCHING. THIS RESULTED IN AN INCREASE IN THE SURGERY TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 18106909 ↗
• MalfunctionNov 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE THE DEVICE BROKE WHEN TYING THE KNOT. TO REPLACE THIS THREAD, ANOTHER WAS USED FROM ANOTHER LOT WAS USED, WHICH SEPARATED FROM ITS NEEDLE WHEN STITCHING. THIS RESULTED IN AN INCREASE IN THE SURGERY TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18106851 ↗
• MalfunctionFeb 9, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPLENECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE VETERINARIAN HAD THE FEELING THAT THE THREAD GOT FRAYED IN HER HANDS AS IF IT WAS DISINTEGRATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16340052 ↗
• MalfunctionFeb 9, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPLENECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE VETERINARIAN HAD THE FEELING THAT THE THREAD GOT FRAYED IN HER HANDS AS IF IT WAS DISINTEGRATING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16340005 ↗
• MalfunctionJun 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OBGYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SUTURING ON THE FASCIA USING AN INSTRUMENT AT 3RD LIGATURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704391 ↗
• MalfunctionJun 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OBGYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SUTURING ON THE FASCIA USING AN INSTRUMENT AT 3RD LIGATURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704389 ↗
• MalfunctionJun 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OBGYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SUTURING ON THE FASCIA USING AN INSTRUMENT AT 3RD LIGATURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704387 ↗