Z-1595-2020 Class II Ongoing
FDA device recall Z-1595-2020 was initiated by Medtronic MiniMed on June 27, 2019 and is designated Class II. 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 unauthorize… The recall status is ongoing. Affected quantity: 68,598.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- June 27, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,598
Product Description
Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
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.
Distribution Pattern
US nationwide distribution including Puerto Rico.
Code Information
All software versions 2.6A or lower. Available outside the US only.