FDAFDA · Food and drugs·Recall number Z-1581-2020
MiniMed Insulin Pump, model # MMT-508
Published April 1, 2020 · Recall initiated: June 27, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic MiniMed
- Distributor
- US nationwide distribution including Puerto Rico.
- Lot
- All Software Versions
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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