Caprosyn SC-5686GRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521034877), received between Jul 1, 2019 and Feb 22, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE PATIENT, THE THREAD BROKE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13578363 ↗InjuryJul 1, 2019Break; Break
ACCORDING TO THE REPORTER, 2 DAYS AFTER AN OPEN VARICECTOMY SURGERY, THE SKIN CLOSURE WIRE BROKE. IT WAS NOTED THAT THE SURGEON HAD TO TAKE BACK THE PATIENT¿S SCAR.
Patient problems: No Code Available
MAUDE report 8747258 ↗
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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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