Recall Z-1258-2022— Tandem Diabetes Care Inc
Class II · Ongoing
Class II FDA medical device recall by Tandem Diabetes Care Inc, initiated 2020-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology. Reason: Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia..
- Recalling firm
- Tandem Diabetes Care Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-09-10
- Firm location
- San Diego, CA, United States
Product description
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Reason for recall
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
Data sourced from openFDA. This site is unofficial and independent of the FDA.