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 StatesAdapter Vario07612367015387
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 |
|---|---|---|---|---|
| 2014-08-27 | NAI | No action indicated | Medela Inc | 0 |
| 2014-08-27 | NAI | No action indicated | Medela Inc | 0 |
| 2014-02-26 | NAI | No action indicated | Medela Inc | 0 |
| 2014-02-26 | NAI | No action indicated | Medela Inc | 0 |
| 2012-05-25 | OAI | Official action indicated | Medela Inc | 7 |
| 2012-05-25 | OAI | Official action indicated | Medela Inc | 7 |
| 2011-11-21 | NAI | No action indicated | Medela Inc | 0 |
| 2011-11-21 | NAI | No action indicated | Medela Inc | 0 |
| 2011-08-09 | VAI | Voluntary action indicated | Medela Inc | 0 |
| 2011-08-09 | VAI | Voluntary action indicated | Medela Inc | 0 |
| 2011-02-25 | WL | Warning Letter | Medela Inc | — |
| 2011-02-25 | WL | Warning Letter | Medela Inc | — |
| 2010-11-01 | OAI | Official action indicated | Medela Inc | 0 |
| 2010-11-01 | OAI | Official action indicated | Medela Inc | 0 |
| 2010-01-21 | VAI | Voluntary action indicated | Medela Inc | 7 |
| 2010-01-21 | VAI | Voluntary action indicated | Medela Inc | 7 |
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