MONOCRYL MCP845GRecalls & 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 10705031046719), received between Mar 5, 2020 and Oct 18, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break3
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2022Break; Material Separation; Break; Material Separation
DURING THE SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE WIRE WAS BREAKING AND RELEASING FROM THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15624025 ↗MalfunctionJul 14, 2020Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SHANK FRACTURED DURING SUTURING. THE NOSE SECTION DID NOT STAY IN PLACE WHEN MOLDED TO FACE; AND NEEDED CONSTANT ADJUSTMENT AS RIDES TOWARDS EYE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10271751 ↗MalfunctionMar 5, 2020Break; Break
IT WAS REPORTED THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROTOMY PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE NEEDLE TIP BROKE OFF. THE NEEDLE TIP WAS PICKED UP AND DISPOSED OF. THE NEEDLE TIP WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9796239 ↗
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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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