Recall Z-0427-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care, Inc.
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
| Date | Nov 5, 2025 (initiated Oct 6, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 readi |
| Quantity | 17,745 |
| Distribution | US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, PT, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc., Jul 10, 2023 |
| K233044 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc., Oct 5, 2023 |
| K240309 | Tandem Mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc., Mar 21, 2024 |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology Tandem Diabetes Care, Inc., Jul 26, 2024 |