Reported Jun 22, 2022 · Ongoing
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Tandem Diabetes Care Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care Inc · 11075 Roselle St · San Diego, CA · 92121-1204
Is this the product you have?
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
- and tslim X2 Insulin Pump with Basal-IQ Technology
- Lot codes and dates
- Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier
- Amount recalled
- 5,206
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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