SentieroRecalls & reported problems across all models
PATH medical GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Sentiero model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 3 models of Sentiero by PATH medical GmbH in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Sentiero recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 26, 2023Open, Classified
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0404-2024 · Root cause: Process change control · Recall details · FDA record ↗
- Sep 26, 2023Open, Classified
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0402-2024 · Root cause: Process change control · Recall details · FDA record ↗
- Sep 26, 2023Open, Classified
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0401-2024 · Root cause: Process change control · Recall details · FDA record ↗
Sentiero models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sentiero 100098Audiometer1 recall0 reports
- Sentiero 100098-SAudiometer1 recall0 reports
- Sentiero 100098-S2Audiometer1 recall0 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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