MiniMed Paradigm Model 511 Insulin Pump
Reported: April 1, 2020 Initiated: June 27, 2019 #Z-1582-2020
Product Description
MiniMed Paradigm Model 511 Insulin Pump
Reason for Recall
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.
Details
- Recalling Firm
- Medtronic MiniMed
- Units Affected
- 30,479
- Distribution
- US nationwide distribution including Puerto Rico.
- Location
- Northridge, CA
Frequently Asked Questions
What product was recalled? ▼
MiniMed Paradigm Model 511 Insulin Pump. Recalled by Medtronic MiniMed. Units affected: 30,479.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1582-2020.
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