Medtronic MiniMed Paradigm Insulin pump — Class II medical device recall Z-1587-2020
Ongoing recall by Medtronic MiniMed, reported 2020-04-01, distributed nationwide. The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pu
| Recall number | Z-1587-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Northridge, CA, United States |
| Recall initiated | 2019-06-27 |
| Classified | 2020-03-26 |
| Reported by FDA | 2020-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 88,243 |
| Reason classes | software |
| Model numbers | MMT-522 |
Product
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1587-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.