Tandem Mobi Insulin Pump with Interoperable Technology recall: Software Issue
Tandem Mobi Insulin Pump with Interoperable Technology
Why was Tandem Mobi Insulin Pump with Interoperable Technology recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions 7.9/UDI: 00389152480114
- Product
- Tandem Mobi Insulin Pump with Interoperable Technology
- Recalling firm
- Tandem Diabetes Care, Inc.
- Quantity
- 85 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
- Recall date
- April 23, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)