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 |
|---|---|---|---|---|
| 2026-04-07 | VAI | Voluntary action indicated | Hard Manufacturing Co., Inc. | 2 |
| 2025-03-06 | VAI | Voluntary action indicated | Hard Manufacturing Co., Inc. | 5 |
| 2022-02-24 | VAI | Voluntary action indicated | Hard Manufacturing Co., Inc. | 7 |
| 2019-03-18 | VAI | Voluntary action indicated | Hard Manufacturing Co., Inc. | 4 |
| 2017-03-07 | VAI | Voluntary action indicated | Hard Manufacturing Co., Inc. | 3 |
| 2014-02-28 | VAI | Voluntary action indicated | Hard Manufacturing Co., Inc. | 3 |
| 2011-07-07 | VAI | Voluntary action indicated | Hard Manufacturing Co., Inc. | 6 |
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