t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Reported: June 22, 2022 Initiated: September 10, 2020 #Z-1258-2022
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.
Details
- Recalling Firm
- Tandem Diabetes Care Inc
- Units Affected
- 5,206
- Distribution
- International distribution in the country of Australia.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology. Recalled by Tandem Diabetes Care Inc. Units affected: 5,206.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 22, 2022. Severity: Moderate. Recall number: Z-1258-2022.
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