Z-1258-2022Class II

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

Name: Z-1258-2022 t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Creator: Tandem Diabetes Care Inc
Published: 2020-09-10
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2020-09-10 / Open, Classified / root cause: software

FDA source

Tandem Diabetes Care Inc began a recall of t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology on 2020-09-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1258-2022
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-10
Posted: 2022-06-10
Recalling firm: Tandem Diabetes Care, Inc.
Product: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Product code: PQF Sensor, Glucose, Invasive, Non-Adjunctive
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.
Root cause tag: software
FDA root cause: Software design
Action: On 09/10/2020, correction notices were sent to customers who were asked to acknowledge Low Power Alerts and Low Power Alarms by tapping "OK" and then charging the pump. Further, take the following precautions to ensure that your pump is properly charged, and the pump's battery life does not fall below 25% remaining power: - Periodically check the battery level indicator of your pump - Charge the pump for a short period of time every day (10 to 15 minutes) - Avoid full battery discharges A software update is planned by the end of 2020 that resolves the potential fluctuating battery life display. We will reach out to you to complete the free remote update of your insulin pump when the software update becomes available. Complete a online form to confirm that you have received this important user communication. Customers with questions were encouraged to contact [email protected] In November 2020 software version 6.4.1 was released for all affected insulin pumps except Dexcom G5 Mobile CGM system pumps. On 12/06/2020, Dexcom G5 Mobile CGM system customers were informed that a new software update was available to address the battery issues but that the update requires using the Dexcom G6 CGM system. On 5/24/22, correction notices were sent to customers in Australia to update to the latest software. t:slim X2 insulin pump with Basal-IQ technology version 6.6 and Control-IQ technology version 7.6 are available with the latest software versions. Software update contact: AMSL: [email protected] or 1300 851 056.
Quantity in commerce: 5,206
Distribution: International distribution in the country of Australia.
Product codes and lots: Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1258-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1258-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-22	2022-06-10

Product code PQF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)