InPen Smart Insulin Pen Recall Due to Incorrect Assembly
Medtronic MiniMed is recalling InPen smart insulin pens that may have been incorrectly assembled, potentially causing the insulin cartridge to not fit or the cartridge holder to be difficult to remove. Users without backup insulin could experience temporary hyperglycemia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a malfunction that could prevent proper insulin delivery, creating a risk of harm (hyperglycemia) to diabetic patients. No illnesses or injuries are reported, but the potential for significant health consequences in insulin-dependent patients justifies a High severity rating.
Plain-English summary
Medtronic MiniMed, Inc. is recalling InPen smart insulin pens (REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA) due to incorrect assembly. Approximately 8,986 units have been distributed across the United States.
The pens may have assembly defects that result in either the insulin cartridge not fitting into the cartridge holder, or the cartridge holder being difficult to remove from the pen. If these assembly issues are present and users do not have backup insulin available, they may experience temporary hyperglycemia.
Users who believe they have a recalled pen should contact Medtronic MiniMed, Inc. for further instructions.
The recalled product
- Product
- InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
- Manufacturer
- Medtronic MiniMed, Inc.
- Affected units
- 8,986
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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