MiniMed Paradigm 512 Insulin pump recall
MiniMed Paradigm 512 Insulin pump
Why was MiniMed Paradigm 512 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?
All Software Versions
- Product
- MiniMed Paradigm 512 Insulin pump
- Recalling firm
- Medtronic MiniMed
- Quantity
- 34,777
- Distribution
- US nationwide distribution including Puerto Rico.
- Recall date
- April 1, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)