Merocel® 400150Recalls & reported problems
Medtronic Xomed, Inc. · PACKING 400150 100PK MICRO SPHERES 3MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20681490104566), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT MEROCEL WAS DROPPED INSIDE OF A PATIENT BUT WERE UNABLE TO REACH TO FISH IT OUT. ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT A LEFT MIDDLE EAR EXCISION GLOMUS TYMPANICUM PROCEDURE WAS BEING PERFORMED, THE MICROSPHERE WAS PLACED IN THE INNER EAR, THE SURGEON BELIEVES, IT FELL INTO THE LEFT EUSTACHIAN TUBE. NO X-RAYS WERE TAKEN AS THE MICROSPHERES ARE NOT RADIOPAQUE. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: Foreign Body In Patient
MAUDE report 16699779 ↗
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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