Medtronic MiniMed, Inc.: Alternate Controller Enabled Insulin Infusion Pump
Updated 3 hours ago ()
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).
- Tags
- FDA recall, medical device, class 2, Clinical Chemistry, Software design, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 2: Information Security Risk Management
- Source record id
- Z-2698-2026
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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