t:slim X2 insulin pump recallZ-1811-2022 · Tandem Diabetes Care Inc · initiated May 24, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tandem Diabetes Care Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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: [email protected] or 1300 851 056; New Zealand, NZMS [email protected] (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: [email protected] 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-
Recall details
- Recall number
- Z-1811-2022
- Status
- Open, Classified
- Initiated by the company
- May 24, 2022
- Posted by the FDA
- Sep 26, 2022
- Recalling firm
- Tandem Diabetes Care Inc
- Quantity
- 31,100
- Product code
- PQF
- Distribution
- US: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC, MS, GA, NV, HI, MN, WA, IN, AR, ID, CO, IA, MO, MT, PA, WI, NH, MD, WV, KS, NM, OR, KY, DE, ND, CT, NJ, TN, WY, AK, SD, DC, RI, IA, PR, VT, PT, VI, NC. OUS: Australia, New Zealand, South Africa
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
26 devices in the FDA device registry whose identifier appears in the recall's code information.
- t:slim X2 Insulin Pump with Control-IQ 1006402Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls18 deaths159,247 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000886Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall17 deaths108,656 reports
- t:slim X2 Insulin Pump with Control-IQ 1006408Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls12 deaths92,526 reports
- t:slim X2 Insulin Pump with Control-IQ 1006404Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall18 deaths43,718 reports
- t:slim X2 Insulin Pump with Control-IQ 1005011Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall3 deaths35,600 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000912Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall2 deaths30,219 reports
- t:slim X2 5.0 Insulin Pump 1000885Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall2 deaths17,224 reports
- t:slim X2 Insulin Pump with Basal-IQ 1006379Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls16,712 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000898Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall6 deaths16,106 reports
- t:slim X2 5.0 Insulin Pump 1000911Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor2 recalls2 deaths15,928 reports
- t:slim X2 Insulin Pump with Control-IQ 1006406Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls1 death10,997 reports
- t:slim X2 Insulin Pump with Basal-IQ 1006373Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall7,488 reports
- t:slim X2 Insulin Pump 1000103Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1 death7,327 reports
- t:slim X2 5.0 Insulin Pump 1000897Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall2 deaths6,444 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000892Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall1 death5,216 reports
- t:slim X2 Insulin Pump with Control-IQ 1005013Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall5,097 reports
- t:slim X2 Insulin Pump with Basal-IQ 1005706Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall2 deaths5,094 reports
- t:slim X2 Insulin Pump with Control-IQ 1005012Tandem Diabetes Care, Inc. · Interoperable Automated Glycemic Controller1 recall4,129 reports
- t:slim X2 5.x Insulin Pump 1003808Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor2 recalls1 death2,526 reports
- t:slim X2 Insulin Pump 1000369Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1,640 reports
- t:slim X2 5.0 Insulin Pump 1000891Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall1,561 reports
- t:slim X2 Insulin Pump with Basal-IQ 1005698Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall1,316 reports
- t:slim X2 Insulin Pump with Basal-IQ 1006375Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall1,016 reports
- t:slim X2 Insulin Pump with Basal-IQ 1006377Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall520 reports
- t:slim X2 Pump, Replacement, Refurb. 1000353Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall320 reports
- t:slim X2 5.0 Insulin Pump 1003487Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor1 recall84 reports
Product lines
- t:slim X2 Insulin PumpTandem Diabetes Care, Inc. · 45 models · 897,233 reports · 4 recalls
- t:slim X2 Insulin Pump with Basal-IQTandem Diabetes Care, Inc. · 14 models · 195,037 reports · 2 recalls
- t:slim X2 Insulin Pump with Control-IQTandem Diabetes Care, Inc. · 11 models · 522,176 reports · 2 recalls
- t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc. · 5 models · 41,241 reports · 2 recalls
- t:slim X2 Insulin PumpTandem Diabetes Care, Inc. · 2 models · 8,967 reports · 1 recall
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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