Tandem Mobi Insulin Pump (Tandem) – vibration motor fault (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tandem Mobi Insulin Pump: Description/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, C
Brand
Tandem Diabetes Care, Inc.
Lot Codes / Batch Numbers
Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013, 1012719/00389152271910, 1013501/00389152350110, 1013655/00389152365510, 1013656/00389152365619, 1013700/00389152370019, 1014081/00389152408170
Products Sold
Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013, 1012719/00389152271910, 1013501/00389152350110, 1013655/00389152365510, 1013656/00389152365619, 1013700/00389152370019, 1014081/00389152408170
Tandem Diabetes Care, Inc. is recalling Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pu due to Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor fa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 10/6/2025, correction notices were mailed or emailed to customers who were informed the following: If your pump shows Malfunction 12, insulin delivery will stop, and the pump becomes non-operational: 1) Promptly acknowledge it by pressing "Silence Alarm". 2) Contact Tandem Diabetes Care Customer Technical Support (CTS) via phone at 1-877-801-6901 or email at Techsupport@tandemdiabetes.com for further assistance. 3) Switch to your backup method of insulin delivery as directed by your physician. 4) Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings. Update your pump software as soon as possible to version 7.9.0.2. You can check your software version within the Mobi Mobile App. Select Settings > Pump > Pump Info. The latest software can be downloaded remotely from within the Tandem Mobi Mobile App. Once logged in to the app, tap "Settings" and then "Pump" to view software updates. Complete the acknowledgement form using link: https://campaign.tandemdiabetes.com/FCA-Malfunction-12 User Guide: https://www.tandemdiabetes.com/docs/default-source/user-guide/user-guide-tandem-mobi-control-iq-7-9-mgdl-en-us-aw1014938.pdf?sfvrsn=872fc4d7_10
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026