MONOCRYL Y494GRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10705031059337), received between Jan 17, 2018 and Apr 23, 2025 — classified as 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Break” (24 reports).

2 other recalls cover devices cleared under the same FDA submission (K964072); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISIONAL BIOPSY OF THE RIGHT INGUINAL LYMPH NODE ON (B)(6) 2025 AND SUTURE WAS USED DURING THE PROCEDURE, THE TIP OF SUTURE NEEDLE BROKE OFF WHILE BEING BROUGHT THROUGH TISSUE BY NEEDLE HOLDER. THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892469 ↗
• MalfunctionOct 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE USING THE SUTURE WAS BREAKING AWAY FROM THE NEEDLE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463329 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE USING THE SUTURE WAS BREAKING AWAY FROM THE NEEDLE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031474 ↗
• MalfunctionMay 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358768 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE PROCEDURE, A 4-0 MONOCRYL SUTURE NEEDLE SNAPPED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851863 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURES ARE BENDING AT THE NEEDLE CAUSING IT TO SNAP AT THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16847068 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURES ARE BENDING AT THE NEEDLE CAUSING IT TO SNAP AT THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846973 ↗
• InjuryMar 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING WOUND CLOSURE, THE WOUND WAS HALFWAY CLOSED WITH DEEP STITCHES WHEN THE NEEDLE BROKE. THE WOUND WAS THEN OPENED UP AND THE BROKEN PIECE WAS PULLED OUT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16588481 ↗
• MalfunctionAug 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WAS A NEEDLE THREAD SEPARATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316762 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14704436 ↗
• MalfunctionDec 20, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SUTURING ON THE MAMMARY DERMIS BY INTERRUPTED SUTURING, THE SUTURE BECAME DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS NOT PULLED PARTICULARLY HARD, BUT IT BECAME DETACHED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049937 ↗
• MalfunctionAug 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE NEEDLE BROKE WHILE PERFORMING DERMOSTITCH OF THE MAMMARY GLAND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334336 ↗
• MalfunctionApr 30, 2020Material 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 PULED OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014586 ↗
• MalfunctionSep 10, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981829 ↗
• MalfunctionSep 10, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981813 ↗
• MalfunctionSep 10, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981807 ↗
• MalfunctionSep 10, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981799 ↗
• MalfunctionSep 10, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981789 ↗
• MalfunctionSep 10, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981776 ↗
• MalfunctionSep 10, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981762 ↗
• MalfunctionSep 10, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981752 ↗
• MalfunctionAug 12, 2019Material 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 NEEDLE FELL OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884838 ↗
• MalfunctionApr 10, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8499232 ↗
• MalfunctionApr 10, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8499154 ↗
• MalfunctionApr 9, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497542 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2025 · Oct 8, 2024 · Open, Classified
  MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
• 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