InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

FDA device recall Z-1650-2025 · posted 2025-04-21 · Open, Classified

Recall details

Recalling firm

Medtronic MiniMed, Inc.

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.

Action taken

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 this device and dispose of it according to local regulations. 3) Complete and return the confirmation form via link: https://info.medtronicdiabetes.com/cartridge-holder Distributors are asked to notify impacted customers. If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.

Root cause

Mixed-up of materials/components

Status

Open, Classified

Product code

FMF

Quantity affected

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

Date initiated

2025-03-04

Date posted

2025-04-21

Location

Northridge, CA

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