MONOCRYL Y845GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031059740), received between Oct 28, 2019 and Sep 9, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Break

  It was reported that a patient underwent a C-section on an unknown date and suture was used. During the procedure, the suture broke and was unable to be located. An X-Ray was done and the patient had be reopened tolocate the suture. Additional information was requested.

  Patient problems: Foreign Body In Patient

  MAUDE report 50694847 ↗
• MalfunctionJul 1, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE NEEDLE SIZE ON THE PACKAGING WAS 16MM, BUT THE SURGEONS BELIEVED THE NEEDLE WAS 13MM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885279 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF A BREAST LESION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087720 ↗
• MalfunctionAug 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST EXCISION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF INTO CUSTOMER AND X-RAY HAD TO COME IN TO TAKE PICTURE TO RETRIEVE NEEDLE. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359455 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC TUMOR EXCISION LYMPH NODE DISSECTION IN (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9245205 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC TUMOR EXCISION LYMPH NODE DISSECTION IN (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9245198 ↗

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