Coated VICRYL J353HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031039209), received between Nov 9, 2018 and Jun 10, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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.

• MalfunctionJun 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGICAL PROCEDURE, THE SURGEON REPORTS THAT THE WIRE DISCONNECTED FROM THE NEEDLE, THERE WAS NO RUPTURE OF THE WIRE. THE WIRE UNRECESSED FROM THE NEEDLE. ACCORDING TO REPORTS, THE SAME HAS HAPPENED TWO MORE TIMES WITH THE SAME THREAD. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177255 ↗
• MalfunctionJun 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGICAL PROCEDURE OF HYSTERECTOMY, THE SURGEON REPORTS THAT THE WIRE DISCONNECTED FROM THE NEEDLE, THERE WAS NO RUPTURE OF THE WIRE. THE WIRE UNRECESSED FROM THE NEEDLE. ACCORDING TO REPORTS, THE SAME HAS HAPPENED TWO MORE TIMES WITH THE SAME THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169557 ↗
• MalfunctionJun 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGICAL PROCEDURE OF HYSTERECTOMY, THE SURGEON REPORTS THAT THE WIRE DISCONNECTED FROM THE NEEDLE, THERE WAS NO RUPTURE OF THE WIRE. THE WIRE UNRECESSED FROM THE NEEDLE. ACCORDING TO REPORTS, THE SAME HAS HAPPENED TWO MORE TIMES WITH THE SAME THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169555 ↗
• MalfunctionJun 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGICAL PROCEDURE OF HYSTERECTOMY, THE SURGEON REPORTS THAT THE WIRE DISCONNECTED FROM THE NEEDLE, THERE WAS NO RUPTURE OF THE WIRE. THE WIRE UNRELEASED FROM THE NEEDLE. ACCORDING TO REPORTS, THE SAME HAS HAPPENED TWO MORE TIMES WITH THE SAME THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169554 ↗
• MalfunctionMar 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022, AND SUTURE WAS USED. SURGICAL THREADS HAD COME LOOSE FROM THE NEEDLE DURING USE. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18925057 ↗
• MalfunctionMar 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022, AND SUTURE WAS USED. SURGICAL THREADS HAD COME LOOSE FROM THE NEEDLE DURING USE. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18925047 ↗
• MalfunctionFeb 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SUTURING PROCESS, THE NEEDLE CAME OFF THE THREAD. IN VIEW OF WHAT HAPPENED, IT WAS NOT POSSIBLE TO USE THE WIRE, AND IT WAS NECESSARY TO REPLACE IT WITH ANOTHER ONE OF THE SAME FUNCTION AND ANOTHER LOT NUMBER, IN ORDER TO CONTINUE MEETING THE PATIENT'S NEEDS AT THAT TIME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436335 ↗
• MalfunctionDec 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE THREAD BROKE DURING THE SURGICAL PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038695 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN ON (B)(6) 2022 AN UNKNOWN DATE AND SUTURE WAS USED. WHEN OPENING THE VICRYL SUTURE THE NEEDLE TIP WAS BROKEN. THIS SUTURE WAS NOT USED ON THE PATIENT. THEY REMOVED ALL OF THE SUTURES WITH THE SAME LOT#. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123077 ↗
• MalfunctionSep 27, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538293 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING. THERE WAS NO NEEDLE FRAGMENT, SO THE SURGEON THINKS IT WAS SUTURE PULL-OFF. WHEN THE SALES REP CHECKED THE NEEDLE, IT SEEMED TO BE NEEDLE BREAKAGE BY VISUAL INSPECTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509648 ↗
• InjuryNov 9, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT CESAREAN SECTION PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE ON THE UTERINE MUSCLE LAYER. THE POSITION OF THE NEEDLE FRAGMENT WAS CONFIRMED BY X-RAY. AN ADDITIONAL PROCEDURE WAS PERFORMED ON THE SAME DAY TO REMOVE THE NEEDLE FRAGMENT. THE PATIENT HAS BEEN DISCHARGED FROM THE FACILITY. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 8055809 ↗