| | Class 1 Device Recall Tandem Mobi Insulin Pump with Interoperable Technology |  |
| Date Initiated by Firm | October 06, 2025 |
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| Date Posted | November 05, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0427-2026 |
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| Recall Event ID |
97662 |
| 510(K)Number | K223213 K233044 K240309 K241078 |
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| Product Classification |
Alternate controller enabled insulin infusion pump - Product Code QFG
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| 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, 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 |
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| Code Information |
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 |
Recalling Firm/
Manufacturer |
Tandem Diabetes Care, Inc.
12400 High Bluff Dr
San Diego CA 92130-3077
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| For Additional Information Contact | Ms Susan Morrison
858-366-6880 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Software design |
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| 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 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
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| Quantity in Commerce | 17,745 |
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| 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
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = QFG
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