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U.S. Department of Health and Human Services

Class 1 Device Recall Tandem Mobi Insulin Pump with Interoperable Technology

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 Class 1 Device Recall Tandem Mobi Insulin Pump with Interoperable Technologysee related information
Date Initiated by FirmFebruary 27, 2025
Date PostedApril 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1520-2025
Recall Event ID 96417
510(K)NumberK241078 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
ProductTandem Mobi Insulin Pump with Interoperable Technology
Code Information Software versions 7.9/UDI: 00389152480114
Recalling Firm/
Manufacturer		 Tandem Diabetes Care, Inc.
12400 High Bluff Dr
San Diego CA 92130-3077
For Additional Information ContactMs. Susan Morrison
877-801-6901
Manufacturer Reason
for Recall		A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
FDA Determined
Cause 2		Software Design Change
ActionOn February 28, 2025 Tandem Diabetes Care contacted each affected customer by phone concerning a Urgent Medical Device Correction. On March 11, 2025, Tandem followed up with a "Urgent Medical Device" Recall notification via E-Mail to affected consignees. Tandem ask consignees to take the following action: 1. Turn off Control-IQ+ immediately. You may continue to use your pump without Control-IQ active. Your pump will deliver insulin based on your programmed active personal profile and will not automatically adjust insulin delivery. 2. Please refer to the user guide provided with your pump for more detailed instructions. 3. Continue using your Tandem pump as described in the User Guide. 4. Pay attention to all system alerts and alarms. 5. Always carry back-up supplies.
Quantity in Commerce85 units
DistributionUS: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = QFG
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