Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delive…

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.

Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).

On January 30, 2026, Tandem Diabetes Care issued a Urgent Medical Device Recall Notice to affected consignees via E-Mail. Tandem ask consignees to take the following actions: 1. Discard your existing User Guide. 2. Refer to the corrected User Guide version 7.8.1 which is available online at www.tandemdiabetes.com/cs-cz/support/resources/documents for accurate instructions on using your t:slim X2 Insulin Pump. 3. Physical copies of the corrected User Guide are being produced to replace the incorrect versions. If you would like a physical copy of the corrected User Guide, you may contact A. Import s customer service line to arrange for a replacement. 4.As requested above, please complete the online form acknowledging receipt of this notice. 5. Should you experience any device-related serious incidents, please report them to your distributor, a local contact point, or the State Institute for Drug Control.

• FDA enforcement recordOfficial FDA database entry for Z-1636-2026
• FDA 510(k) clearance · K232380The device's official FDA premarket clearance record
• FDA 510(k) clearance · K232382The device's official FDA premarket clearance record
• FDA 510(k) clearance · K243823The device's official FDA premarket clearance record
• FDA 510(k) clearance · K250792The device's official FDA premarket clearance record
• FDA 510(k) clearance · K250798The device's official FDA premarket clearance record
• FDA device classification · QFGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5730The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tandem Diabetes Care, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.