The FDA issued a public notice on Apr. 22 highlighting its Class I recall classification for Tandem Diabetes Care Inc‘s (NASDAQ: TNDM) (FRA: TD5A) Tandem Mobi insulin pumps.
The agency gave the action its most serious rating because the problem may cause serious injury or death if users do not correct it. More than 17,700 pumps in the United States carry the faulty software.
The software glitch triggers a false “Malfunction 12” alert. The pump wrongly detects a motor failure, stops delivering insulin and cuts communication with continuous glucose monitors and the Tandem Mobi mobile app. Patients can develop dangerous high blood sugar or hyperglycemia. In severe cases, this leads to hospitalization. So far, the FDA has reported four serious injuries but no deaths have occured.
Tandem first sent an Urgent Medical Device Correction letter to affected customers on Oct. 6, 2025. The company urged users to download a free software update as soon as possible. The FDA reviewed the issue and classified the correction as a Class I recall on Nov. 5. This month, the FDA posted a more visible public notice on its website and multiple news outlets reported the details widely.
Tandem has told users to act fast. Patients can download the free software update through the Tandem Mobi app. They are also advised to keep a backup insulin delivery method ready, check blood sugar levels often and contact Tandem support if the alarm sounds. The pumps will remain on the market while users apply the fix.
This recall creates new costs for Tandem. The company must pay for software updates, extra customer support and possible replacements. Lawyers have begun investigating claims from injured patients, which could lead to lawsuits and legal expenses.
Operationally, Tandem faces heavier service demands and must rebuild confidence among doctors and users in a competitive market. These pressures may slow growth and affect quarterly results.
This Tandem action comes amid a surge in recalls for diabetes tech. In March, Insulet Corp (NASDAQ: PODD) (FRA: GOV) recalled certain Omnipod 5 pumps after insulin leaks caused 18 serious events, including hospitalizations for high blood sugar and a severe condition called diabetic ketoacidosis.
Moreover, Abbott Laboratories (NYSE: ABT) (ETR: ABL) recalled nearly three million FreeStyle Libre 3 glucose sensors last year after false low readings contributed to seven deaths and more than 700 injuries worldwide.
These repeated safety issues highlight growing pains in automated diabetes devices as millions of patients depend on them for daily care.
Read more: Breath Diagnostics advances pre-op pneumonia screening with FDA breakthrough designation
Follow Rowan Dunne on LinkedIn
rowan@mugglehead.com
