MONOCRYL Y833GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031059672), received between Apr 23, 2019 and May 11, 2023 — classified as 4 malfunctions.

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

• MalfunctionMay 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP IPOM PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DR WAS PERFORMING A SURGERY AND WHILE USING THE ETHICON SUTURE, IT GOT SEPARATED FROM NEEDLE'S SWAGE AFTER 2 BITES OF SUTURING. SURGEON USED PROLENE SUTURE FOR REST OF THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915756 ↗
• MalfunctionApr 23, 2019Degraded; Material Separation; Tear, Rip or Hole in Device Packaging; Degraded; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. AFTER TAKING THE SUTURE IN THE HAND, THE SUTURE GOT DETACHED FROM THE NEEDLE. UPON EVALUATION OF THE DEVICE, THE SUTURE COULD NOT BE DISPENSED AS IT HAS BEGUN THE PROCESS OF DEGRADATION. THE FOILS WERE EXAMINED AND SHOWED MULTIPLE WRINKLES AND HOLES IN CAVITY ON BOTTOM FOIL PACKAGES DUE TO EXCESSIVE MANIPULATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541667 ↗
• MalfunctionApr 23, 2019Degraded; Material Separation; Tear, Rip or Hole in Device Packaging; Degraded; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. AFTER TAKING THE SUTURE IN THE HAND, THE SUTURE GOT DETACHED FROM THE NEEDLE. UPON EVALUATION OF THE DEVICE, THE SUTURE COULD NOT BE DISPENSED AS IT HAS BEGUN THE PROCESS OF DEGRADATION. THE FOILS WERE EXAMINED AND SHOWED MULTIPLE WRINKLES AND HOLES IN CAVITY ON BOTTOM FOIL PACKAGES DUE TO EXCESSIVE MANIPULATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541666 ↗
• MalfunctionApr 23, 2019Degraded; Material Separation; Tear, Rip or Hole in Device Packaging; Degraded; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. AFTER TAKING THE SUTURE IN THE HAND, THE SUTURE GOT DETACHED FROM THE NEEDLE. UPON EVALUATION OF THE DEVICE, THE SUTURE COULD NOT BE DISPENSED AS IT HAS BEGUN THE PROCESS OF DEGRADATION. THE FOILS WERE EXAMINED AND SHOWED MULTIPLE WRINKLES AND HOLES IN CAVITY ON BOTTOM FOIL PACKAGES DUE TO EXCESSIVE MANIPULATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541663 ↗

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