Recall Z-1520-2025— Tandem Diabetes Care, Inc.
Class I · Ongoing
Class I FDA medical device recall by Tandem Diabetes Care, Inc., initiated 2025-02-27. It names one FDA 510(k) clearance: K241078. Product: Tandem Mobi Insulin Pump with Interoperable Technology. Reason: 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..
- Recalling firm
- Tandem Diabetes Care, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-02-27
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Tandem Mobi Insulin Pump with Interoperable Technology
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.