Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417

What happened

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.

Who may be affected

• People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
• A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What to do

Affected products and models

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

Units affected

See official FDA record

Category

Insulin pumps

Timeline

1. Feb 27, 2025

   Recall initiated

   Date recorded by the FDA.

2. Apr 11, 2025

   Posted by FDA

   The recall event appeared in the FDA source.

3. Oct 8, 2026

   Last checked

   MedWatcher last reconciled this record with the openFDA export.