Tandem Diabetes Care recalled 1,380 insulin infusion pumps distributed internationally in the Czech Republic and Slovakia after translation errors in the Czech user guide could cause unintended insulin delivery. The most significant error told users to verify the infusion set is connected to the body when it should be confirming it is not connected. Following this instruction could result in a hyp
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tandem Diabetes Care, Inc. or your healthcare provider for instructions. Notification method: Letter
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Tandem insulin infusion pumps deliver basal and bolus doses of insulin via a disposable cartridge. The device uses a motor-driven mechanism and is programmable by the user to manage insulin delivery.
A translation error in the Czech user guide could cause unintended insulin delivery by instructing users to verify the infusion set is connected to the body, when it should be confirmed as not connected. This could lead to hypoglycemia.
This recall is not indicated as part of a broader industry pattern.
The recall highlights the risk of user-facing documentation causing incorrect device operation. Consumers should stop using affected pumps and await manufacturer guidance to avoid hypoglycemia.
On device label, packaging, recall letter, or the manufacturer’s website
Timelines vary; expect 4-8 weeks for remedy processing in typical cases
Keep the recall notification, purchase receipts, model numbers, and all correspondence with the manufacturer
Model: Version 7.8.1 / UDI: (01)008500066132625 Sold internationally in the Czech Republic and Slovakia Recall date: 2026-01-30 Reported date: 2026-04-01 Price: Unknown Quantity: 1,380 units
No injuries or incidents have been reported.
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