MONOCRYL MCP495GRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031046580), received between Feb 1, 2024 and May 7, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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 Integrity Problem1
- Material Separation1
Patient problems
- Impaired Healing1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE WIRE HAD PROBLEMS IN THE PROCEDURE, SINCE THE WIRE DROPPED FROM THE NEEDLE AND IT WAS NECESSARY TO OPEN ANOTHER ENVELOPE TO CONTINUE THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE, AND NO ADDITIONAL PROCEDURES WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19260180 ↗InjuryFeb 1, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GALLBLADDER REMOVAL PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. POST-OP, ALL OF THE OTHER SUTURE LINES HAD HEALED ASIDE FROM THE BELLYBUTTON. THE SUTURE WAS NOT HEALING AND WOULD NOT SCAB. THE PATIENT HAD SILVER PUT ON THE SUTURING TO HELP STERILIZE IT AND CAUTERIZE IT ON (B)(6)2024. IT WAS CALLED IT A SPLIT STITCH. THE SUTURE WOULD NOT DISSOLVE. IT WAS STATED THAT POSSIBLE OUTCOMES FOR PATIENT INCLUDE HAVING THE SUTURE TAKEN OUT AND RE-SUTURED WITH A DIFFERENT TYPE. IT IS UNCLEAR IF THE PATIENT IS HAVING A REACTION/ALLOGENIC REACTION TO THE SUTURE OR NOT.
Patient problems: Impaired Healing
MAUDE report 18627675 ↗
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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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