MONOCRYL MCP523HRecalls & reported problems
Ethicon, LLC · Antibacterial Undyed 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 10705031046627), received between Mar 9, 2020 and Jun 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (3 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 Separation3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- 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.
MalfunctionJun 20, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE PULLED RIGHT OFF THE SUTURE ONCE THE SURGEON STARTED USING IT. THIS HAPPENED WITH TWO SUTURES FROM THE SAME BOX. THE SURGEON WAS NOT PULLING HARD ON THE SUTURE, AND IT SHOULD NOT HAVE PULLED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299137 ↗MalfunctionJun 20, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE PULLED RIGHT OFF THE SUTURE ONCE THE SURGEON STARTED USING IT. THIS HAPPENED WITH TWO SUTURES FROM THE SAME BOX. THE SURGEON WAS NOT PULLING HARD ON THE SUTURE, AND IT SHOULD NOT HAVE PULLED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299135 ↗MalfunctionMar 9, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING PROCEDURE, THE NEEDLE POPPED OFF OF THE DEVICE. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9809301 ↗
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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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