Tandem Diabetes Care recalls pumps with Czech language user guide errors that could lead to unintended insulin delivery and hypoglycemia. Affected pumps have version 7.8.1 and UDI (01)008500066132625.
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 Diabetes Care is recalling insulin pumps that have a Czech language user guide with translation errors. These errors could cause users to mistakenly think the infusion set is connected when it's not, leading to unintended insulin delivery and potentially dangerous low blood sugar events.
The user guide incorrectly instructs users to check if the infusion set is connected when it should say it's not connected. If users follow this wrong instruction, they might deliver insulin when it shouldn't be delivered, causing low blood sugar.
People using Tandem insulin pumps with the Czech language user guide version 7.8.1 are affected. Those with diabetes who rely on these pumps for insulin delivery are most at risk.
Check for the version number 7.8.1 on the pump's software. The unique device identifier (UDI) is (01)008500066132625. These pumps were sold with the Czech language guide.
Look for version 7.8.1 on the pump's software or user guide.
Reach out to Tandem Diabetes Care for guidance on next steps.
The Czech language user guide has translation errors that could cause users to mistakenly think the infusion set is connected when it's not, leading to unintended insulin delivery.
The recall record does not mention a specific fix or remedy for the user guide error.
Check for version 7.8.1 and the unique device identifier (UDI) (01)008500066132625 on the pump's software or user guide.
We’ve drafted a message you can send Tandem to request your refund or repair — edit it as you like.
Subject: Recall Z-1636-2026 — Tandem Tandem Hello, I own a Tandem that is covered by recall Z-1636-2026 from Tandem. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
