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 wi
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- January 30, 2026
International distribution in the countries of Czech Republic, Slovakia.
What's affected?
- Product
- 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).
- Lot code
- Version 7.8.1/ UDI: (01)008500066132625
Additional details
Version 7.8.1/ UDI: (01)008500066132625
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,380 units.
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