Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- United StatesAVANTI10705032010306
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 |
|---|---|---|---|---|
| 2022-06-29 | VAI | Voluntary action indicated | Cordis US Corp | 0 |
| 2022-06-29 | VAI | Voluntary action indicated | Cordis US Corp | 0 |
| 2018-01-12 | VAI | Voluntary action indicated | Cordis US Corp | 1 |
| 2018-01-12 | VAI | Voluntary action indicated | Cordis US Corp | 1 |
| 2017-09-15 | VAI | Voluntary action indicated | AccessClosure, Inc., A Cardinal Health Company | 1 |
| 2016-07-06 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-07-06 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-03-31 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-03-31 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-02-12 | VAI | Voluntary action indicated | Cardinal Health Mexico 244 S de RL de CV | 3 |
| 2016-02-01 | NAI | No action indicated | AccessClosure, Inc., A Cardinal Health Company | 0 |
| 2015-05-08 | NAI | No action indicated | Cordis US Corp | 0 |
| 2015-05-08 | NAI | No action indicated | Cordis US Corp | 0 |
| 2014-08-05 | VAI | Voluntary action indicated | AccessClosure, Inc., A Cardinal Health Company | 3 |
| 2014-04-03 | NAI | No action indicated | Cardinal Health Mexico 244 S de RL de CV | 0 |
| 2014-01-30 | NAI | No action indicated | Cordis US Corp | 0 |
| 2014-01-30 | NAI | No action indicated | Cordis US Corp | 0 |
| 2013-12-18 | NAI | No action indicated | Cordis US Corp | 0 |
| 2013-12-18 | NAI | No action indicated | Cordis US Corp | 0 |
| 2012-07-03 | NAI | No action indicated | Cordis US Corp | 0 |
| 2011-02-16 | WL | Warning Letter | Cordis LLC | — |
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