Reported Nov 12, 2025 · Ongoing
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both…
Tandem Diabetes Care, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care, Inc. · 12400 High Bluff Dr · San Diego, CA · 92130-3077
Is this the product you have?
- Tandem Mobi Insulin PumpDescription/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081
- Lot codes and dates
- Software versions
7.6.0.17.6.0.3and 7.7.0.1
- Catalog/UDI-DI
1010750/003891520750131012719/003891522719101013501/003891523501101013655/003891523655101013656/003891523656191013700/003891523700191014081/00389152408170
- Software versions
- Amount recalled
- 17,745
Where it was sold
Why it was recalled
Stop using this product now
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.
Using this product could cause serious injury, illness or death — stop using it now.
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