Syneture VLOCN2105Recalls & reported problems
Covidien LP · Absorbable Wound Closure Device · Class 2 · Implant
All models of Syneture (12)
Data updated Oct 18, 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 10884521762558), received between Oct 31, 2023 and May 23, 2025 — classified as 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA WITH GASTRIC BYPASS PROCEDURE, WHILE CLOSING THE MESENTERIC DEFECT, THE NEEDLE DETACHED AND FELL INTO THE PATIENT¿S ABDOMINAL CAVITY. IT WAS RETRIEVED USING GRASPERS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079700 ↗MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR PROCEDURE, WHEN INSERTING THE STRAND THROUGH THE METALLIC TROCAR, THE NEEDLE AND STRAND SEPARATED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18044654 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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