FDA Medical Device Recalls (openFDA)
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 number
- Z-1811-2022
- Recalling firm
- Tandem Diabetes Care Inc
- 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
- Status
- Open, Classified
- Initiated
- 2022-05-24
- Posted
- 2022-09-26
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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-
- Quantity
- 31,100
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PQF
- Firm FEI
- 3007981285
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28