Caprosyn SC-587Recalls & 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 10884521034952), received between May 13, 2020 and Aug 22, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break4
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW DEVICE FROM ANOTHER BRAND WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20027905 ↗MalfunctionAug 22, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY PROCEDURE, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW DEVICE FROM ANOTHER BRAND WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20027312 ↗MalfunctionNov 30, 2021Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS CUTICULAR WHILE CLOSURE OF THE SKIN, THE 3 THREADS BROKE INITIALLY ON THE FIRST BITE AND IN BETWEEN. THE SURGEON USED ANOTHER COMPANY'S PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12896800 ↗MalfunctionMay 13, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME OFF THE THREAD AND THE SUTURE MATERIAL DISINTEGRATED AND WAS LEFT IN THE PACKAGE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE.
Patient problems: No Information
MAUDE report 10053408 ↗
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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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