t:slim X2 insulin pump recall: Software Issue
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…
Why was t:slim X2 insulin pump 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Tandem Diabetes Care Inc
- 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
- Recall date
- October 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)