How do I get a refund or replacement for this recall?

Stop using the recalled product immediately. Follow the manufacturer's instructions on the official recall notice for returning or disposing of the product. Depending on the recall, you may receive a full refund, a replacement product, or a free repair. Visit the official source link on this page for claim instructions.

How do I know if my product is affected by this recall?

Check the product name, model number, lot number, or purchase date against the official recall notice. The official source link on this page contains the full list of affected units. If in doubt, stop using the product and contact the manufacturer directly.

Product Recalls & Refunds Online / National

Tandem Diabetes Care, Inc.: t:slim X2 Insulin Pump with Interoperable Technology

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.. Recalled by Tandem Diabetes Care, Inc.. Distribution: US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH,

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Category Product Recalls & Refunds

Location National

Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.

Source Official Source ↗

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