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device recall
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Medtronic MiniMed, Inc. device recall (Cls II)

November 13, 2025updated 6mo ago
community read0 votes

InPen App, Model/CFN Number: MMT-8061 (Android Users) — Reason: 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. — Status: Ongoing

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same company · ±60 days · 6

  • device recallMedtronic MiniMed, Inc. device recall (Cls II)Nov 2, 2025
  • device 510kMedtronic Sofamor Danek USA, Inc. — CD Horizon™ Spinal System (510k cleared)Oct 24, 2025
  • device 510kMedtronic Sofamor Danek USA, Inc. — Infinity™ OCT System (510k cleared)Oct 24, 2025
  • device pmaMedtronic Minimed, Inc. — MiniMed 780G System (PMA supplement)Dec 5, 2025
  • device pmaMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Dec 5, 2025
  • device recallMedtronic MiniMed, Inc. device recall (Cls II)Oct 21, 2025

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