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U.S. Department of Health and Human Services

Class 2 Device Recall InPen Insulin Pen

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 Class 2 Device Recall InPen Insulin Pensee related information
Date Initiated by FirmMarch 04, 2025
Date PostedApril 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1650-2025
Recall Event ID 96421
510(K)NumberK160629 K190487 K192841 K201337 K242775 
Product Classification Syringe, piston - Product Code FMF
ProductInPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Code Information REF/UDI-DI(GTIN)/Lot: MMT-105NNBLNA/763000827182/D0020, D0034, D0036, D0038, D0045, D0046, D0050, D0057; MMT-105NNGYNA/763000827199/D0026, D0037, D0039, D0041, D0042, D0043, D0049; MMT-105NNPKNA/763000827205/D0029, D0030, D0040, D0051, D0062; MMT-105ELBLNA/763000827151/D0021, D0033, D0035, D0044, D0059, D0060, D0061; MMT-105ELGYNA/763000827168/D0031, D0032, D0047, D0068; MMT105ELPKNA/763000827175/D0027, D0028, D0048
FEI Number 3003166194
Recalling Firm/
Manufacturer		 Medtronic MiniMed, Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact
818-725-6731
Manufacturer 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.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn 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.
Quantity in Commerce8,986
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FMF
510(K)s with Product Code = FMF
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