MONOCRYL Y844GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031059726), received between Mar 13, 2020 and Apr 19, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, WHEN THE SUTURE WAS REMOVED FROM THE PACKET, THE NEEDLE WAS FOUND TO NOT BE THE CORRECT 3/8 SHAPE. THE ISSUE WAS DETECTED PRIOR TO USE ON THE PATIENT AND ANOTHER SUTURE WAS OPENED FOR THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773338 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT WHEN OPENING SUTURE PACKET, THE SUTURE WAS NOT ATTACHED TO THE THREAD. IT WAS NOT USED ON THE PATIENT AND REPLACED IT WITH ANOTHER SUTURE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832472 ↗

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