MONOCRYL Y334HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031058811), received between Feb 12, 2020 and Sep 5, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN SPAY VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER CLINIC THAT SUTURE WAS USED ON A PATIENT DURING A SPAY PROCEDURE ON (B)(6) 2025. POST-OP, ON (B)(6) 2025, PATIENT WAS TAKEN TO EMERGENCY DUE TO TOTAL DEHISCENT OF INCISION. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22984441 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN SPAY VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER CLINIC THAT SUTURE WAS USED ON A PATIENT DURING A SPAY PROCEDURE ON (B)(6) . POST-OP, ON 8/4 PATIENT WAS TAKEN TO EMERGENCY DUE TO TOTAL DEHISCENT OF INCISION. THE DEVICE IS AVAILABLE FOR RETURN.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22984430 ↗
• MalfunctionDec 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAH PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE COMING AWAY FROM SWAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987086 ↗
• MalfunctionDec 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAH PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE COMING AWAY FROM SWAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987057 ↗
• MalfunctionFeb 12, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE BREAKS WHEN PULLING ON NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699944 ↗

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.