A massive recall of Medtronic implantable devices could have major implications for nearly 350,000 patients. If you had an implantable cardioverter difibrilator (ICD) or a cardiac resynchronization therapy device (CRT-D) manufactured by Medtronic between October 2017 and present, you may have a potential claim. Our team is investigating these potential claims and would love the opportunity to discuss your situation if you have suffered complications from one of these devices.
The FDA has tagged this as a Class I recall, the most severe classification, meaning there is a “reasonable probability that the use of the product will cause serious adverse health consequences or death”. The recall of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) was initiated in May 2023 after receiving reports of 28 incidents and 22 injuries. This recall involves devices manufactured and distributed between October 2017 and June 2023. These devices are designed to be implanted into the heart to monitor and regulate heart rhythm. They are designed to detect irregular heart rhythms and deliver an electric shock when needed. However, the devices manufactured after October 2017 feature a glassed feedthrough which may initiate an incorrect short-circuiting protection (SCP) feature. This has the potential to lead to delivery of a low or no energy output when high voltage therapy is needed. A reduced-energy shock, or no energy shock at all, is dangerous if the arrythmia is life-threatening. Failure to correct heart rhythm could lead to cardiac arrest.
This recall comes a year after the company recalled more than 20,000 ICDs in the US for a similar issue affecting the delivery of shock energy during high voltage therapy, and two years after it recalled 240,000 defibrillators because of the potential for a rapid decrease in battery life.
Our team is currently investigating claims involving these potentially faulty medical devices. If you or someone you love has one of the recalled devices, feel free to reach out to our office.
As always, if you need us, we’d be honored to help.