Caprosyn CC-914Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521034303), received between Dec 27, 2018 and Nov 7, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC OBSTETRIC PROCEDURE, THE NEEDLE AND SUTURE WERE SEPARATED FROM THE JUNCTION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15744326 ↗MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC OBSTETRIC PROCEDURE, WHEN THE DEVICE WAS OPENED JUST BEFORE USE, THE ABSORBABLE SUTURE AND NEEDLE WERE SEPARATED FROM THE JUNCTION. THE SURGEON USED ANOTHER PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15740362 ↗InjuryDec 27, 2018Break; Break
ACCORDING TO THE REPORTER, FOLLOWING A CESAREAN SECTION PROCEDURE, AFTER CLOSING THE UTERUS, WHEN THE NEEDLE WAS PLACED IN THE SAFETY BOX, THE NURSE REALIZED THAT THEY "HAVE" USED A BROKEN NEEDLE SINCE THEY SAW THAT THE TIP OF THE NEEDLE REMAINED TO THE NEEDLE HOLDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8199109 ↗
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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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