N/A 8227304Recalls & reported problems
Medtronic Xomed, Inc. · ELECTRODE 8227304 5PK PRASS PR 18MM ROHS · Class 2
Data updated Oct 16, 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 20763000038292), received between Mar 14, 2025 and Jan 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
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.
MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING PAROTID SURGERY, ONE OF THE ELECTRODES STOPPED WORKING. AFTER REPOSITIONING ALSO, THE PROBLEM PERSISTED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001125 ↗MalfunctionMar 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING THE INSPIRE SLEEP APNEA PROCEDURE/IMPLANT, THE PATIENT WAS DRAPED AT 12:39. THE ELECTRODES STARTED MAKING UNUSUAL NOISE WITH RESPONSES ON BOTH RED AND BLUE CHANNELS EXCEEDING 20,000 V. ANOTHER ELECTRODE CHECK WAS PERFORMED, WHICH STOPPED THE NOISE FOR ABOUT 3 MINUTES. HOWEVER, THE NOISE RESUMED, SO BOTH THE BLUE AND RED ELECTRODES WERE INVERTED TO SEE IF THE ISSUE WOULD STOP FOR A LONGER PERIOD. AFTER ANOTHER 3-5 MINUTES, THE NOISE STARTED AGAIN. THIS TIME, ONLY THE RED ELECTRODE WAS INVERTED, AND THE GREEN/GROUND WIRE WAS REMOVED FOR 2 FULL SECONDS BEFORE PLUGGING IT BACK IN. BY 12:47, THE NOISE RESUMED, BUT PROPER RESPONSES FOR THE PLACEMENT OF THE INSPIRE IMPLANT HAD ALREADY BEEN OBTAINED, SO IT WAS LEFT ALONE. THE PI BOX "WIRELESS" AND THE "WIRED MUTING CORD" WERE USED. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT, AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604034 ↗
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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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