Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1586-2020 — Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715

U.S. FDA — Device Enforcement · United States · 2019-06-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1586-2020
Date of alert
2019-06-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic MiniMed
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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