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 |
|---|---|---|---|---|
| 2019-03-28 | VAI | Voluntary action indicated | GC America, Inc. | 6 |
| 2019-03-28 | VAI | Voluntary action indicated | GC America, Inc. | 6 |
| 2015-10-26 | OAI | Official action indicated | GC America, Inc. | 0 |
| 2015-10-26 | OAI | Official action indicated | GC America, Inc. | 0 |
| 2014-07-25 | NAI | No action indicated | GC Asahi Corporation | 0 |
| 2014-06-06 | NAI | No action indicated | GC America, Inc. | 0 |
| 2014-06-06 | NAI | No action indicated | GC America, Inc. | 0 |
| 2013-06-13 | VAI | Voluntary action indicated | GC America, Inc. | 0 |
| 2013-06-13 | VAI | Voluntary action indicated | GC America, Inc. | 0 |
| 2013-02-05 | VAI | Voluntary action indicated | GC Europe N.V. | 1 |
| 2012-11-21 | WL | Warning Letter | GC America, Inc. | — |
| 2012-11-21 | WL | Warning Letter | GC America, Inc. | — |
| 2012-07-13 | OAI | Official action indicated | GC America, Inc. | 0 |
| 2012-07-13 | OAI | Official action indicated | GC America, Inc. | 0 |
| 2010-02-08 | NAI | No action indicated | GC America, Inc. | 0 |
| 2010-02-08 | NAI | No action indicated | GC America, Inc. | 0 |