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).
Enforcement
- Recall Number
- Z-1636-2026
- Event ID
- 98478
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Tandem Diabetes Care, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 1, 2026
- Initiation Date
- January 30, 2026
- Classification Date
- March 25, 2026
- Address
- 12400 High Bluff Dr, San Diego, CA, 92130-3077, United States
Description
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).
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.
Version 7.8.1/ UDI: (01)008500066132625
International distribution in the countries of Czech Republic, Slovakia.
1,380 units