Recall Z-1636-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care, Inc.
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 u
| Date | Mar 25, 2026 (initiated Jan 30, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| Action | 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. Im |
| Quantity | 1,380 units |
| Distribution | International distribution in the countries of Czech Republic, Slovakia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc., Nov 3, 2023 |
| K232382 | Control-IQ Technology Tandem Diabetes Care, Inc., Nov 3, 2023 |
| K243823 | Control-IQ+ technology Tandem Diabetes Care, Inc., Feb 24, 2025 |
| K250792 | t:slim X2 insulin pump with interoperable technology Tandem Diabetes Care, Inc., Sep 24, 2025 |
| K250798 | Control-IQ+ technology Tandem Diabetes Care, Inc., May 21, 2025 |