[Recalled] Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E — The action is being initiated due to potential cybersecurity vulnerabilities re… | FDA 2019-06-27
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E |
|---|---|
| Brand / manufacturer | Medtronic MiniMed |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1585-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 27 June 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
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 →
Related recalls from Medtronic MiniMed
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.