Tandem Diabetes Care initiated a Class II medical device recall affecting battery-operated insulin infusion pumps distributed internationally in Czech Republic and Slovakia. The Czech language user guide contained translation errors, the most significant being incorrect instructions for verifying infusion set connection status. Users were directed to confirm the set IS connected when the correct instruction should direct users to confirm it is NOT connected.

Medical device manufacturers and distributors with affected products should verify their inventory for Czech/Slovak language user guides and coordinate with Tandem Diabetes Care for corrected documentation. Healthcare providers treating patients using these devices should confirm patients have received accurate user guides. The recall remains ongoing with no specific return deadline provided.