MONOCRYL Y345HRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031058897), received between Apr 30, 2018 and Mar 12, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. WHILE CLOSING THE UTERUS, AFTER TWO OR THREE PASSES THE NEEDLE CAME OFF OF THE SUTURE. TWO ADDITIONAL SUTURES WERE OPENED WITH THE SAME ISSUE. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE OF A DIFFERENT LOT. THERE WAS EXTRA BLOOD LOSS, BUT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. EXACT AMOUNT OF EXTRA BLOOD LOSS WAS NOT PROVIDED. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18885030 ↗
• MalfunctionMar 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. WHILE CLOSING THE UTERUS, AFTER TWO OR THREE PASSES THE NEEDLE CAME OFF OF THE SUTURE. TWO ADDITIONAL SUTURES WERE OPENED WITH THE SAME ISSUE. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE OF A DIFFERENT LOT. THERE WAS EXTRA BLOOD LOSS, BUT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. EXACT AMOUNT OF EXTRA BLOOD LOSS WAS NOT PROVIDED. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18885025 ↗
• MalfunctionMar 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. WHILE CLOSING THE UTERUS, AFTER TWO OR THREE PASSES THE NEEDLE CAME OFF OF THE SUTURE. TWO ADDITIONAL SUTURES WERE OPENED WITH THE SAME ISSUE. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE OF A DIFFERENT LOT. THERE WAS EXTRA BLOOD LOSS, BUT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. EXACT AMOUNT OF EXTRA BLOOD LOSS WAS NOT PROVIDED. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18885022 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. SEVERAL SUTURES WERE BREAKING DURING USE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777829 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2023, AND SUTURE WAS USED. SEVERAL SUTURES WERE BREAKING DURING USE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777826 ↗
• MalfunctionJan 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FELL APART. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152117 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FELL APART. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925274 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FELL APART. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925263 ↗
• MalfunctionJul 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A DOG UNDERWENT A OVARIOHYSTERECTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE FELL OFF THE SUTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10315191 ↗
• MalfunctionDec 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE THREAD CAME OF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507144 ↗
• MalfunctionDec 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE THREAD CAME OF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507046 ↗
• MalfunctionDec 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE THREAD CAME OF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507041 ↗
• MalfunctionDec 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE THREAD CAME OF THE NEEDLE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9455022 ↗
• MalfunctionNov 12, 2019Material Frayed; Material Frayed

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SUTURE WAS USED DURING THE PROCEDURE, IT WAS FRAYING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311524 ↗
• MalfunctionSep 3, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT WITHOUT EFFORT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8955501 ↗
• MalfunctionAug 29, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946694 ↗
• MalfunctionApr 30, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IN 2018, SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AT 1 TO 3 CM FROM NEEDLE WHEN IN USE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473457 ↗
• MalfunctionApr 30, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IN 2018, SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AT 1 TO 3 CM FROM NEEDLE WHEN IN USE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473447 ↗
• MalfunctionApr 30, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IN 2018, SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AT 1 TO 3 CM FROM NEEDLE WHEN IN USE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473437 ↗
• MalfunctionApr 30, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IN 2018, SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AT 1 TO 3 CM FROM NEEDLE WHEN IN USE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7472415 ↗

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.