FDAClass IIApril 1, 2020

MiniMed Insulin Pump recall

MiniMed Insulin Pump, model # MMT-508

Why was MiniMed Insulin Pump recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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Product
MiniMed Insulin Pump, model # MMT-508
Recalling firm
Medtronic MiniMed
Quantity
64,174 units
Distribution
US nationwide distribution including Puerto Rico.
Recall date
April 1, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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