MONOCRYL MCP346HRecalls & reported problems
Ethicon, LLC · Antibacterial Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture · Class 2 · Implant
All models of MONOCRYL (127)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031046436), received between May 27, 2020 and Aug 27, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Separation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UTERINE TISSUE CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE INTO TWO PIECES WHILE SUTURING. APPROXIMATELY THREE-QUARTERS OF THE NEEDLE BECAME EMBEDDED IN THE TISSUE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22905460 ↗MalfunctionJan 25, 2024Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USE, WHEN GETTING THE SUTURE OUT OF THE PACKAGE, THE NEEDLE APPEARED TO NOT BE CONNECTED TO THE SUTURE AT ALL. UPON EVALUATION OF THE RETURNED DEVICE, SHORT INSERTION WAS OBSERVED IN THE STRAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18583863 ↗MalfunctionMay 27, 2020Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10091923 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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