Tandem Diabetes Care recalls t:slim X2 insulin pumps with specific software versions due to potential hypoglycemia, hyperglycemia, or diabetic ketoacidosis risks from malfunctioning features.
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 certain t:slim X2 insulin pumps that may malfunction, leading to incorrect blood sugar readings or other issues that could cause dangerous low or high blood sugar levels. This recall is important for people using these pumps to prevent serious health complications.
The insulin pumps may have issues like inaccurate battery displays, touchscreen problems, or unexpected system behavior that could lead to incorrect insulin delivery. This might cause blood sugar levels to drop too low (hypoglycemia) or rise too high (hyperglycemia), potentially leading to diabetic ketoacidosis.
People with diabetes who use the recalled t:slim X2 insulin pumps are most at risk. Those with specific software versions listed in the recall notice should check their pump details.
Check your pump's software version and serial number. The recall includes specific model numbers and software versions listed in the product details. Contact Tandem Diabetes Care if you have one of these models.
Review your pump's software version and serial number to see if it matches the recalled models listed in the notice.
If your pump is listed, contact Tandem Diabetes Care to arrange a switch-out or software update.
No, the recall does not require immediate stoppage. You can continue using the pump but should check for the specific recalled software versions and contact Tandem Diabetes Care for a switch-out.
The affected software versions include 4.3.5.2, 4.3.6, 5.0.1, 5.0.4, 5.3.1.1, 6.0.4, 6.3.1.1, 6.4, and 7.3.1.1, 7.4 as listed in the recall notice.
Yes, specific parts like 1000886, 1000898, 1004219, 1005706, 1006373, or 1006375 may need replacement if your pump is listed, but some parts require no action if the software is up to date.
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-1811-2022 — Tandem Diabetes Care Tandem Diabetes Care Hello, I own a Tandem Diabetes Care that is covered by recall Z-1811-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
