Tandem Diabetes Care, Inc. (link company) issued an update to a March 2024 recall of its t:slim X2 insulin pump mobile app, notifying customers that the app update is still causing the harmful battery depletion defect.
Tandem’s Mobile App Still Causing Battery Depletion Post-Update
Despite a March recall and a following update, Tandem’s t:slim X2 application is still causing the battery-depleting defect.
More from Recalls
• By
The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.
• By
The company is recalling Pipeline Vantage 021 and 027 models because they pose a higher than normal risk of failing to properly attach to blood vessel walls, which can cause thrombosis, stroke or death. The recall for 027 is a product removal and for 021 is an update to the instructions for use.
• By
The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.
• By
Medical device recalls exceeded 1,000 in 2024, according to a recently published recall index report from Sedgwick. More than 10% of those recalls were class I, the FDA’s most serious category.
More from Policy & Regulation
• By
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
• By
People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.
• By
Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.