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 States1.7 mm RenalCryo™ Cryoprobe00810563020793
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 |
|---|---|---|---|---|
| 2023-09-20 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2023-09-20 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2022-09-07 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2017-09-01 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2017-07-20 | VAI | Voluntary action indicated | VARIAN MEDICAL SYSTEMS HAAN GMBH | 2 |
| 2017-01-12 | VAI | Voluntary action indicated | Varian Medical Systems Imaging Laboratory GmbH | 1 |
| 2016-12-15 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-12-15 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-08-31 | NAI | No action indicated | Varian Medical Systems Inc | 0 |
| 2016-08-10 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-08-10 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-01-15 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-01-15 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2015-07-10 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2015-07-10 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2015-05-20 | VAI | Voluntary action indicated | Varian Medical Systems, Inc. | 2 |
| 2015-05-20 | VAI | Voluntary action indicated | Varian Medical Systems, Inc. | 2 |
| 2014-06-06 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2014-06-06 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2014-06-02 | NAI | No action indicated | Varian Medical Systems Inc | 0 |
| 2010-05-17 | WL | Warning Letter | Varian Medical Systems, Inc. | — |
| 2010-05-17 | WL | Warning Letter | Varian Medical Systems, Inc. | — |
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