Cyberonics® Tunneler Model 402Recalls & reported problems
Livanova USA, Inc. · Tunneler · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05425025750238), received between Feb 24, 2021 and Feb 24, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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 18, 2026.
Most reported problems
Device problems
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2021Separation Failure
VNS TUNNELER USED FROM LEFT NECK TO LEFT CHEST, SURGEON ATTEMPTED TO REMOVE THE TIP TO PASS LEAD BUT UNABLE TO SCREW OFF. ULTIMATELY, NEEDED TO GET A NEW TUNNELER. SURGEON ABLE TO USE TRACK MADE BY OTHER TUNNELER. MANUFACTURER RESPONSE FOR INSTRUMENT, SURGICAL, NON-POWERED, CYBERONICS® TUNNELER MODEL 402 (PER SITE REPORTER). FOLLOWING UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11372024 ↗
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- V. Mueller NL1098Steris Corporation · INSTRUMENT, SURGICAL, NON-POWERED1 report
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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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