Recall Z-1811-2022— Tandem Diabetes Care Inc
Class II · Ongoing
Class II FDA medical device recall by Tandem Diabetes Care Inc, initiated 2022-05-24. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Tandem Diabetes Care Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-05-24
- Firm location
- San Diego, CA, United States
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.