FDA Device recall Z-1583-2020
MiniMed Paradigm 512 Insulin pump
- FDA Device
- Class II
- ongoing
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of MiniMed Paradigm 512 Insulin pump by Medtronic Minimed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1583-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-06-27 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Minimed |
| Distribution | US |
Product
MiniMed Paradigm 512 Insulin pump
Reason
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.
Identifiers
| code_info | All Software Versions |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1583-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.