MONOCRYL Y740DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031059559), received between Apr 23, 2018 and May 30, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE WHEN SUTURING WITH A SLIGHT FORCE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022361 ↗
• MalfunctionMay 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE WHEN SUTURING WITH A SLIGHT FORCE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022330 ↗
• MalfunctionJun 1, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT GYN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE SURGEON PULLED THE SUTURE THROUGH TISSUE A DIFFERENT TYPE OF SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7560423 ↗
• MalfunctionJun 1, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT GYN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE SURGEON PULLED THE SUTURE THROUGH TISSUE A DIFFERENT TYPE OF SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7560374 ↗
• MalfunctionJun 1, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT GYN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE SURGEON PULLED THE SUTURE THROUGH TISSUE A DIFFERENT TYPE OF SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7560319 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450943 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450907 ↗

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.