Tandem pumps are battery-operated infusion pumps recall
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to…
Why was Tandem pumps are battery-operated infusion pumps recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 7.8.1/ UDI: (01)008500066132625
- 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…
- Recalling firm
- Tandem Diabetes Care, Inc.
- Quantity
- 1,380 units
- Distribution
- International distribution in the countries of Czech Republic, Slovakia.
- Recall date
- April 1, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)