T Connect App Used With T Slim X2 Insulin Pump Recalled After Reports of Injures

Tandem Diabetes Care, Inc. Issues Recall For Apple IOS T:Connect Mobile App Used With t:slim X2 Insulin Pump with Control-IQ Technology; 224 Injuries Reported So Far

T Connect App Used With T Slim X2 Insulin Pump Recalled After Reports of Injures

CHICAGO, ILLINOIS (June 30, 2024) – Medical device company Tandem Diabetes Care, Inc has issued a recall of the t:connect mobile app used in connection with the t slim X2 insulin pump.

The t:slim X2 insulin pump is used to deliver insulin under the skin at a set interval. It has the ability to connect securely with other devices.

A recall has been issued because there is an issue with the software that may cause the mobile app to crash. When the mobile app crashes, this can cause the device to dispense additional cycles of insulin to patients, which can be extremely dangerous.

As of April 15, 2024, there have been 224 reports of injuries and no reports of deaths.

Liability For Injuries Involving Medical Devices

Millions of Americans rely on medical devices in order to get treatment for diabetes and other health conditions. Most people use medical devices without any safety incidents, but many people have been seriously injured or killed by medical devices. According to The Regulatory Review, “[based on] data from the U.S. Food & Drug Administration (FDA), more than 80,000 deaths and 1.7 million injuries have been linked to medical devices in the past decade.” Companies should take a number of steps in order to ensure that their medical devices are safe.

  • Regulatory Compliance: Companies should be familiar with and adhere to all safety guidelines set forth by the FDA and other regulatory agencies.
  • Pre-Market Approval: Companies should obtain the necessary approvals or clearances before releasing their product.
  • Risk Management: Companies should develop and implement measures to mitigate identified risks for medical devices.
  • Third-Party Inspections: Companies should use internal and external audits to ensure that their medical devices are compliant with all safety standards.

Companies that manufacture medical devices or the software that they use could be liable if someone is injured by their product. Every company that makes medical devices has a legal obligation to ensure that they are reasonably safe. This requires that they make sure their software or devices are rigorously tested. When a company makes a product with design defects, they could be liable for any resulting injuries. Several steps should be taken after any patient is injured by a medical device.

  • Medical records related to the incident should be preserved.
  • A report of the incident should be created.
  • An experienced product liability attorney should be contacted.

Companies that make medical devices or software tend to focus on making sure that their devices work 99% of the time. But they often neglect to consider the edge cases that could cause safety concerns. In many cases, those edge cases may not even be present until many weeks, months, or years later, as the operating systems for computers or phones get updated. It is important that victims of medical device accidents understand that they do have rights. They are able to seek compensation through a civil claim.

Getting Legal Help After Injuries Involving Medical Devices

We at Horwitz Horwitz & Associates were deeply concerned to hear about the hundreds of injuries involving the T Connect App used With T Slim X2 Insulin Pumps. There needs to be a thorough investigation into the full scope and scale of the injuries. It is our hope that measures are taken to prevent other incidents like this. People should be able to rely on their medical devices without fear of being seriously injured.

Have you or someone that you care about been injured by the T Connect App used with the T Slim X2 Insulin Pump? You may have legal recourse. Our team of product liability attorneys is here to help in any way that we can. We care deeply that patients are aware of their rights and that those rights are being protected. Whether you just have legal questions or need any type of support, we are here for you. You can reach out to us anytime at (312) 564-4256.