Tandem Diabetes Care Inc t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Brand
Tandem Diabetes Care Inc
Lot Codes / Batch Numbers
Pump/UDI-DI/Software Versions/Distributor Instructions: t:slim X2 insulin pump/00852162004781, 00852162004798, 00853052007240/ 4.3.5.2, 4.3.6/ For Distributors, All Parts, Contact Recalling Firm to Switch Out, t:slim X2 insulin pump with Dexcom G5/853052007257, 853052007271, 853052007295, 853052007318, 853052007967, 853052007981/ 5.0.1, 5.0.4, 5.3.1.1/ For Distributors, All Parts, Contact Recalling Firm to Switch Out, t:slim X2 insulin pump with Basal-IQ technology/853052007264, 853052007288, 853052007301, 853052007325, 850006613373, 850006613380, 850006613700, 850006613717, 850006613724, 850006613731/ 6.0.4, 6.3.1.1, 6.4/ For Distributors: 1) Parts: 1000886, 1000898, 1004219, 1005706, 1006373 or 1006375, Contact Recalling Firm to Switch Out, 2) Parts: 1010004, 1010005, 1010006, No Action Required, Software is Up to Date, t:slim X2 insulin pump with Control-IQ technology/ 850006613229, 850006613205, 850006613212, 850006613762, 850006613779, 850006613786, 850006613793/ 7.3.1.1, 7.4/ For Distributors: 1) Parts: 1005011, 1005012, 1006402 or 1006404, Contact Recalling Firm to Switch Out, 2) Parts: 1010009, 1010010, 1010011, No Action Required, Software is Up to Date
Products Sold
Pump/UDI-DI/Software Versions/Distributor Instructions: t:slim X2 insulin pump/00852162004781, 00852162004798, 00853052007240/ 4.3.5.2, 4.3.6/ For Distributors, All Parts, Contact Recalling Firm to Switch Out; t:slim X2 insulin pump with Dexcom G5/853052007257, 853052007271, 853052007295, 853052007318, 853052007967, 853052007981/ 5.0.1, 5.0.4, 5.3.1.1/ For Distributors, All Parts, Contact Recalling Firm to Switch Out; t:slim X2 insulin pump with Basal-IQ technology/853052007264, 853052007288, 853052007301, 853052007325, 850006613373, 850006613380, 850006613700, 850006613717, 850006613724, 850006613731/ 6.0.4, 6.3.1.1, 6.4/ For Distributors: 1) Parts: 1000886, 1000898, 1004219, 1005706, 1006373 or 1006375, Contact Recalling Firm to Switch Out, 2) Parts: 1010004, 1010005,1010006, No Action Required, Software is Up to Date; t:slim X2 insulin pump with Control-IQ technology/ 850006613229, 850006613205, 850006613212, 850006613762, 850006613779, 850006613786, 850006613793/ 7.3.1.1, 7.4/ For Distributors: 1) Parts: 1005011, 1005012, 1006402 or 1006404, Contact Recalling Firm to Switch Out, 2) Parts: 1010009,1010010, 1010011, No Action Required, Software is Up to Date
Tandem Diabetes Care Inc is recalling t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ due to Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen St. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.
Recommended Action
Per FDA guidance
On 5/24/22, and 7/7/22, correction notices sent to customers in Australia and New Zealand 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 available with latest software versions. Software update contact: Australia, AMSL: diabetes@amsl.com.au or 1300 851 056; New Zealand, NZMS tandemupdate@nzms.co.nz (Questions: 0508 634 103) On 7/26/22, correction notices were mailed or emailed in the United States to healthcare providers and distributors. Recalling firm contact: Techsupport@tandemdiabetes.com Providers asked to instruct patients to update pump software. Software update called version 6.6.0.1 for Basal-IQ technology and version 7.6.0.1 for Control-IQ technology. Check software version on the pump: options > my pump > pump info and arrow down to software version. See user guide and to visit https://support.tandemdiabetes.com/hc/en-us/articles/1500011452302-How-do-I-check-what-software-version-is-on-my-pump-video- Latest software can be downloaded remotely from a computer. Visit https://portal.tandemdiabetes.com and login with their t:connect account credentials. Once logged in, click the MY DEVICES to view available software updates. Perform software update via the Tandem Device Updater (TDU), with precautions and instructions provided in user TDU guide: https://www.tandemdiabetes.com/docs/default-source/product-documents/tandem-device-updater/aw-1004796_c-user-guide-tandem-device-updater-5-4-artwork.pdf. Acknowledge correction notice receipt: https://go.tandemdiabetes.com/Field-Correction-Notice-X.6_US.html Distributors with impacted part numbers asked to contact the recalling firm s distribution team. On 8/4/22, users sent correction notice to update pump software. See above for acknowledgment form link and software update instructions. Prescription and training may be required if pump is out-of-warranty and not currently using Control-IQ technology, can only update to Basal-
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026