inpenRecalls & reported problems across all models
Medtronic Minimed, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one inpen model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 7 models of inpen by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
inpen recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 13, 2025Open, Classified
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.
Z-0958-2026 · Root cause: Software Design Change · Recall details · FDA record ↗
- Mar 4, 2025Open, Classified
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.
Z-1650-2025 · Root cause: Mixed-up of materials/components · names 6 of these models · Recall details · FDA record ↗
inpen models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- inpen™ MMT-105ELBLNACalculator, drug dose1 recall0 reports
- inpen™ MMT-105ELGYNASyringe, piston1 recall0 reports
- inpen™ MMT-105ELPKNACalculator, drug dose1 recall0 reports
- inpen™ MMT-105NNBLNASyringe, piston1 recall0 reports
- inpen™ MMT-105NNGYNACalculator, drug dose1 recall0 reports
- inpen™ MMT-105NNPKNASyringe, piston1 recall0 reports
- InPen MMT-8061Calculator, drug dose1 recall0 reports
Other Medtronic Minimed, Inc. products
- MiniMed 670G23 models · 141,169 reports · 4 recalls
- MiniMed 630G23 models · 65,972 reports · 6 recalls
- Paradigm REAL-Time Revel180 models · 49,838 reports · 2 recalls
- MiniMed 530G71 models · 48,745 reports · 1 recall
- MiniMed670G2 models · 28,871 reports · 3 recalls
- MiniMed630G2 models · 6,656 reports · 5 recalls
- MiniMed Reservoir6 models · 4,545 reports
- PARADIGM REAL-time95 models · 2,862 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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