Recall Z-1650-2025— Medtronic MiniMed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2025-03-04. It names 5 FDA 510(k) clearances: K242775, K201337, K190487 and 2 more. Product: InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA. Reason: Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia..
- Recalling firm
- Medtronic MiniMed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-04
- Firm location
- Northridge, CA, United States
510(k) clearances named in this recall
5 on FDA's record- K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
- K201337 — InPen System
- K190487 — InPen Dose Calculator
- K192841 — InPen System
- K160629 — InPen
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Reason for recall
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.
Data sourced from openFDA. This site is unofficial and independent of the FDA.