t:slim X2 and Mobi Insulin Pump Software Defect Affecting Glucose Readings
Tandem Diabetes Care is recalling t:slim X2 and Mobi insulin pumps with software version 7.9 due to a defect that miscalculates glucose trends during sensor connection gaps, potentially causing incorrect insulin dosing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified by the FDA as Class I, the highest classification for medical device recalls. FDA Class I recalls must receive a minimum severity score of 4 per the rubric. The software defect can cause severe hypoglycemia or hyperglycemia, both potentially life-threatening conditions.
Plain-English summary
Tandem Diabetes Care is recalling certain t:slim X2 and Mobi insulin pumps with software version 7.9 that are used with Control IQ+ technology. The recall affects 63 units distributed across multiple US states including Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.
A software defect in version 7.9 causes 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. This gap occurs when the continuous glucose monitor (CGM) sensor loses connection with the pump. The incorrect glucose reading causes the pump to deliver the wrong amount of insulin.
When the pump delivers too little insulin, users may experience severe hypoglycemia (dangerously low blood sugar). When it delivers too much, users may experience severe hyperglycemia (dangerously high blood sugar). Both conditions can be life-threatening and require immediate medical attention.
Users of affected t:slim X2 or Mobi pumps should contact Tandem Diabetes Care immediately for instructions. Do not rely solely on the pump's glucose trend calculations, especially when your CGM sensor connection has been interrupted. Contact your healthcare provider if you experience symptoms of hypoglycemia or hyperglycemia.
The recalled product
- Product
- t:slim X2 Insulin Pump with Interoperable Technology
- Manufacturer
- Tandem Diabetes Care, Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- software-defect
- hypoglycemia
- hyperglycemia
- incorrect-insulin-delivery
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software versions 7.9/UDI: 00389152407012
Distribution
Distributed in 29 states:
- 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
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03