MONOCRYL Y358HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031059023), received between Jun 9, 2020 and Jan 22, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (K960653); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON USED THE Y358H*1EA TO SUTURE SKIN, WHEN TIE THE SUTURE, THIS WERE SUTURE WAS BROKEN. SO, SHE USED OTHER Y358H TO COMPLETE THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212368 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES BROKE OFF NEEDLE MID SURGERY. PHYSICIANS HAD DIFFICULTY LOCATING NEEDLE IN THE UTERUS, FOUND BEFORE CLOSURE, X-RAY WAS NOT NEEDED & COUNTS CORRECT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607902 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES BROKE OFF NEEDLE MID SURGERY. PHYSICIANS HAD DIFFICULTY LOCATING NEEDLE IN THE UTERUS, FOUND BEFORE CLOSURE, X-RAY WAS NOT NEEDED & COUNTS CORRECT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607899 ↗
• MalfunctionDec 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE CLOSING THE UTERUS THE NEEDLE EASILY DETACHED FROM THE SWEDGED POINT AS IF IT WAS A CONTROLLED RELEASE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12972073 ↗
• MalfunctionDec 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE CLOSING THE UTERUS THE SUTURE BECAME DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12971992 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CERVICAL PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE FIRST STITCH WAS PULLED, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910868 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258752 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258751 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258749 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258743 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258742 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258740 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258739 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242554 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THEY PROCEDURE WAS DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242543 ↗
• MalfunctionMay 20, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF OF THE NEEDLE WHILE CLOSING THE WOUND. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11857989 ↗
• MalfunctionMay 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE WHILE CLOSING THE WOUND. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847974 ↗
• MalfunctionJun 9, 2020Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE THREAD SEPARATION AFTER OPENING THE OUTER PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, THE FOIL PRESENTED EXCESSIVE HANDLING AND MULTIPLES WRINKLES AND HOLES WERE NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135899 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960653. One submission often covers many models, so check the product and lot details in each record.

• Z-2148-2024 · May 10, 2024 · Open, Classified
  MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345
• Z-1311-2009 · Feb 2, 2009 · Terminated
  MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/or ligation.