Coated VICRYL J258HRecalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 10705031038295), received between Aug 20, 2019 and Aug 25, 2026 — classified as 3 injuries, 152 malfunctions.

The most frequently reported specific device problem is “Material Separation” (137 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); they may or may not involve this specific model.

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 25 most recent of 155 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436655 ↗
• MalfunctionAug 25, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436654 ↗
• InjuryJul 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. DURING VAGINAL DELIVERY THE PROVIDER REPAIRING A VAGINAL LACERATION AND RAN A SUTURE LINE. THE NEEDLE BECAME DETACH AND IT LOCK IN TO THE PERITONEUM SO THEY NEED TO TAKE THE PATIENT TO OPERATING ROOM TO HAVE IT REMOVE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22610133 ↗
• MalfunctionJul 24, 2025Material Separation; Material Separation

  IT WAS REPORTED BY DISTRIBUTOR THAT THEY HAVE A BOX OF SUTURE THAT 2 DIFFERENT PROVIDERS USED, AND THE NEEDLE BROKE OFF AND A KNOT CAME UNDONE FOR ANOTHER ONE. THEY REMOVED THE SUTURE FROM USE. GOT DONE CLOSING THE SUBCUTANEOUS TISSUE. TIED THE KNOT AND MOVED ON TO THE SKIN LAYER AND THE KNOT HAD JUST COME UNDONE. THIS HAPPENED TWICE ON THE PATIENT USING THE SAME SUTURE. ON A DIFFERENT CASE THE NEEDLE JUST POPPED OFF THE SUTURE. THERE WAS 3 MINUTES DELAY TO THESE ACTIVITIES BECAUSE THEY HAD TO KEEP REPEATING THE SAME PART OF THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587884 ↗
• MalfunctionAug 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POST VAGINAL DELIVERY REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. WHEN USING TO SUTURE, WHEN THEY PULLED IT, IT POPPED OFF WITH VERY LITTLE EFFORT. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053260 ↗
• MalfunctionAug 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POST VAGINAL DELIVERY REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. WHEN USING TO SUTURE, WHEN THEY PULLED IT, IT POPPED OFF WITH VERY LITTLE EFFORT. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047300 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POST VAGINAL DELIVERY REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. WHEN USING TO SUTURE, WHEN THEY PULLED IT, IT POPPED OFF WITH VERY LITTLE EFFORT. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041230 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POST VAGINAL DELIVERY REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. WHEN USING TO SUTURE, WHEN THEY PULLED IT, IT POPPED OFF WITH VERY LITTLE EFFORT. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038520 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POST VAGINAL DELIVERY REPAIR ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. WHEN USING TO SUTURE, WHEN THEY PULLED IT, IT POPPED OFF WITH VERY LITTLE EFFORT. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038518 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, NEEDLES CONTINUOUSLY POPPED OFF THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839607 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, NEEDLES CONTINUOUSLY POPPED OFF THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839601 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, NEEDLES CONTINUOUSLY POPPED OFF THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839600 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, NEEDLES CONTINUOUSLY POPPED OFF THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839599 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, NEEDLES CONTINUOUSLY POPPED OFF THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839598 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, NEEDLES CONTINUOUSLY POPPED OFF THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839597 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, NEEDLES CONTINUOUSLY POPPED OFF THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839596 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, NEEDLES CONTINUOUSLY POPPED OFF THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839594 ↗
• MalfunctionOct 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL LACERATION REPAIR PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THE NEEDLE POPPED OF TWICE FROM THE SUTURE TWICE IN THE SAME CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030082 ↗
• MalfunctionOct 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL LACERATION REPAIR PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THE NEEDLE POPPED OF TWICE FROM THE SUTURE TWICE IN THE SAME CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030078 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE WAS BREAKING WHILE SUTURING IN THE LABOR AND DELIVERY UNIT. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402080 ↗
• MalfunctionMay 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT THIRD DEGREE PERINEAL LACERATION REPAIR ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE KEPT BREAKING DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945252 ↗
• MalfunctionMay 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT THIRD DEGREE PERINEAL LACERATION REPAIR ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE KEPT BREAKING DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945246 ↗
• MalfunctionMay 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED OB PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO NEEDLES SNAPPED OFF AT THE SUTURE. THE NEEDLES DID NOT BREAK, BUT DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896843 ↗
• MalfunctionMay 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED OB PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO NEEDLES SNAPPED OFF AT THE SUTURE. THE NEEDLES DID NOT BREAK, BUT DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896836 ↗
• MalfunctionApr 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE WAS BREAKING WHILE SUTURING IN THE LABOR AND DELIVERY UNIT. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824844 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc