Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-06-17 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 1 |
| 2021-10-29 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 5 |
| 2015-09-21 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 1 |
| 2012-07-03 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 8 |
| 2012-06-06 | NAI | No action indicated | Medtronic Xomed, Inc. | 0 |
| 2010-08-05 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 4 |
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