MONOCRYL MCP347HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031046443), received between Apr 13, 2022 and May 28, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K050845, K201996); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD PROBLEMS WITH THE SUTURE MATERIAL BREAKING AWAY FROM THE NEEDLE ITSELF. THIS OCCURRED IN BOTH LAP HYSTERECTOMIES TODAY. THE FIRST IN THE PATIENT AND REQUIRED SEARCHING FOR THE NEEDLE IN THE PATIENT CAVITY AND THE 2ND WHEN DR STRETCHED THE SUTURE BEFORE USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317463 ↗
• MalfunctionMay 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD PROBLEMS WITH THE SUTURE MATERIAL BREAKING AWAY FROM THE NEEDLE ITSELF. THIS OCCURRED IN BOTH LAP HYSTERECTOMIES TODAY. THE FIRST IN THE PATIENT AND REQUIRED SEARCHING FOR THE NEEDLE IN THE PATIENT CAVITY AND THE 2ND WHEN DR STRETCHED THE SUTURE BEFORE USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299207 ↗
• MalfunctionFeb 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS SUTURING THE MUSCLE FASCIA AND AT THE END OF IT THE NEEDLE CAME LOOSE FROM THE SUTURE, THE DOCTOR ARGUES THAT IT WAS A DEFECT IN THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327723 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE OF THE UTERUS ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072579 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. SUTURE MATERIAL USED FOR THE CAESAREAN SECTION BROKE DURING THE PROCEDURE. THE NEEDLE BROKE AND SOME PART OF IT WAS LEFT INSIDE THE UTERUS BUT WAS RETRIEVED BEFORE CLOSING THE SHEATH. THE RADIOGRAPHER WAS NOT REQUIRED AS PER SURGEONS¿ INSTRUCTION BROKEN PARTS MEASURED TOGETHER FOR COMPLETENESS. THE PROCEDURE WAS DELAYED FOR AN UNSPECIFIED AMOUNT OF TIME, AND WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106811 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050845, K201996. One submission often covers many models, so check the product and lot details in each record.

• Z-2149-2024 · May 10, 2024 · Open, Classified
  MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CO
• Z-1312-2009 · Feb 2, 2009 · Terminated
  MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/o