Caprosyn SC-5688GRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521034884), received between Jan 5, 2022 and Jul 27, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
- 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.
MalfunctionJul 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE SCRUB TECH WENT TO OPEN TO PREPARE FOR CASE AND TOOK OUT THE SUTURE FROM THE PACKAGING, IT WAS NOTED THAT THE NEEDLE WAS BROKEN FROM THE SUTURE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15113744 ↗MalfunctionJan 5, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER OPENING THE PACKAGING, THE THREAD BROKE. THE SURGEON USED A COMPETITOR'S DEVICE TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 13169779 ↗
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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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