Recall Z-1650-2025 ยท FMF Syringe, Piston
Medtronic MiniMed, Inc.
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
| Date | Apr 21, 2025 (initiated Mar 4, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | On 3/4/2025, correction notices were sent to customers and distributors informing them of the following: 1) If you have already inserted your insulin cartridge into your device without difficulty removing the cartridge holder, then you can continue normal use. 2) If you have a device from one of the affected lot numbers and have not yet started using it, or have had difficulties in removing the cartridge holder or inserting the insulin cartridge, please call 1-800-646-4633, option 1, or go to https://info.medtronicdiabetes.com/ICH-replacement-form to request a replacement product. Do not use |
| Quantity | 8,986 |
| Distribution | US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH, VA, NY, TN, HI, MA, NJ, PA, CO, WI, GA, CT, NE, OR, LA, NM, SD, ND, IN, NV, WV, RI, AR, NH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160629 | InPen Companion Medical, Inc., Jul 26, 2016 |
| K190487 | InPen Dose Calculator Companion Medical, Inc., Feb 18, 2020 |
| K192841 | InPen System Companion Medical, Inc., Feb 10, 2020 |
| K201337 | InPen System Companion Medical, Inc., Jun 18, 2020 |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) Medtronic Minimed, Nov 12, 2024 |