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FDA device recallVulnerabilitiesPublished December 18, 2025

Medtronic MiniMed, Inc.: Calculator, Drug Dose

When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.

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Tags
FDA recall, medical device, class 2, Anesthesiology, Software Design Change, Open, Classified
Related exam domains
CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 4: Incident Management
Source record id
Z-0958-2026
First seen by InfoSec Signals
9/23/2026

Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.