Tandem Diabetes Care recalls t:slim X2 insulin pumps with specific software versions due to potential hypoglycemia, hyperglycemia, or diabetic ketoacidosis risks. Affected units include models with Dexcom G5 and Basal-IQ technology.
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.
Tandem Diabetes Care is recalling t:slim X2 insulin pumps with certain software versions. These pumps could cause blood sugar issues like hypoglycemia, hyperglycemia, or diabetic ketoacidosis if they malfunction.
The insulin pumps may malfunction in ways that cause inaccurate blood sugar readings or unexpected insulin delivery. This can lead to dangerously low or high blood sugar levels, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
People with diabetes using t:slim X2 insulin pumps with specific software versions are affected. Those who rely on these pumps for insulin delivery are most at risk.
Check if your pump has the model names listed: t:slim X2, t:slim X2 with Dexcom G5, or t:slim X2 with Basal-IQ technology. Look for software versions listed in the recall notice.
Look for the software version on your pump's display or in the pump's settings menu.
If your pump is affected, contact Tandem Diabetes Care to get the latest software update.
Affected software versions include t:slim X2 insulin pump/6.4.1 and earlier; t:slim X2 insulin pump with Dexcom G5/5.2.1, 5.2.2; t:slim X2 insulin pump with Basal-IQ technology/6.3.0.1, 6.4, 6.4.1; and t: slim x2 insulin pump with Control-IQ Technology/7.4, 7.4.3.
Check your pump's model name and software version against the list provided in the recall notice.
Contact Tandem Diabetes Care to get the latest software update to fix the issues.
We’ve drafted a message you can send Tandem Diabetes Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1812-2022 — Tandem Diabetes Care Tandem Diabetes Care Hello, I own a Tandem Diabetes Care that is covered by recall Z-1812-2022 from Tandem Diabetes Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
