Class 1 Device Recall t:slim X2 Insulin Pump with Interoperable Technology

• Date Initiated by Firm: February 27, 2025
• Date Posted: April 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1519-2025
• Recall Event ID: 96417
• 510(K)Number: K232380
• Product Classification: Alternate controller enabled insulin infusion pump - Product Code QFG
• Product: t:slim X2 Insulin Pump with Interoperable Technology
• Code Information: Software versions 7.9/UDI: 00389152407012
• Recalling Firm/ Manufacturer: Tandem Diabetes Care, Inc.; 12400 High Bluff Dr; San Diego CA 92130-3077
• For Additional Information Contact: Ms. 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: Software Design Change
• Action: On 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 Commerce: 63 units
• Distribution: US: 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 Cycle: TPLC 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) Database: 510(K)s with Product Code = QFG