[Recalled] Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. — Some Miethke Shunt System accessories may hav

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.