FDA announced that Tandem Diabetes Care (Tandem) is expanding a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump because of a potential risk for leaking. The potential leaking could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
"The safety of our customers is our top priority. For that reason, even after our previous announcement Tandem’s team continued to perform further testing. Based on this work we recognized that additional cartridge lots could also be at risk for leaking and so we are expanding the scope of this recall," said Kim Blickenstaff, President and CEO of Tandem in a press release. "We are confident that we have identified all of the affected cartridge lots that may have been shipped to customers or distributors and that we have implemented appropriate corrective actions to prevent this from happening in the future."
Tandem has determined that under certain conditions a specific piece of equipment used in the cartridge test process caused the affected cartridges to be at risk for leaking. Tandem has already implemented modifications to the cartridge manufacturing test process to prevent this issue from occurring in the future, and the company’s manufacturing facility is able to support ongoing customer demand. The company says it is working with its customers and distributors to replace cartridges subject to the recall.
Lot recall information is available at FDA.gov.