FDA Alert: Recall for Certain Insulin Pumps (SNF/AL)

Tandem Diabetes Care sent all affected customers an Urgent Medical Device Correction letter for its t:slim X2 Insulin Pumps after identifying a potential speaker-related issue. This issue can trigger an error which will stop insulin delivery and render the pump inoperative. Using the affected product may result in insulin delivery stopping and missing real-time reporting of continuous glucose monitoring, which could cause high blood sugar. In severe cases of hyperglycemia, serious adverse health consequences could occur, including hospitalization or death. To date, there have been 59 reported injuries and no reports of death. This recall involves correcting certain devices through a software update but does not involve removing them from where they are used unless or until a malfunction occurs. The FDA has identified this recall as the most serious type. Get all the details here