Reported Oct 5, 2022 · Ongoing
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim…
Tandem Diabetes Care Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care Inc · 11075 Roselle St · San Diego, CA · 92121-1204
Is this the product you have?
- 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
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 t:slim X2 insulin pump/6.4.1 and earlier 2 t:slim X2 insulin pump with Dexcom G5/5.2.1, 5.2.2 3 t:slim X2 insulin pump with Basal-IQ technology/6.3.0.1, 6.4, 6.4.1 4 t: slim x2 insulin pump with the Control-IQ Technology/7.4, 7.4.3 - Amount recalled
- 8399
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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