Caprosyn CC-811Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
All models of Caprosyn (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523005523), received between Mar 5, 2024 and Mar 5, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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
- Detachment of Device or Device Component4
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN REMOVING THE SUTURE FROM THE PACKAGE, THE FOUR NEEDLES WERE DETACHED FROM THE THREAD.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18842175 ↗MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN REMOVING THE SUTURE FROM THE PACKAGE, THE FOUR NEEDLES WERE DETACHED FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 18842100 ↗MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN REMOVING THE SUTURE FROM THE PACKAGE, THE FOUR NEEDLES WERE DETACHED FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 18842098 ↗MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN REMOVING THE SUTURE FROM THE PACKAGE, THE FOUR NEEDLES WERE DETACHED FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 18842072 ↗
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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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