St. Jude Pacemaker Recall – What We Know So Far

by Terry Bryant

Pacemakers are devices installed in patients to regulate heartbeat. These devices, which are a type of defibrillator, often use electrical shocks or pacing to speed up or slow down a heartbeat. Pacemakers have been used in patients for decades to help extend and improve the quality of life for those with serious heart problems.

Unfortunately, they are also regularly called into question for the harm they cause patients. One of the most recent examples stems from pacemakers made by St. Jude Medical. Hundreds of these devices have failed unexpectedly, and up to 400,000 worldwide are currently covered in a massive St. Jude Pacemaker recall.

How St. Jude Medical Pacemakers Fail

Like so many highly-publicized recalls and consumer safety scares in recent years, the issue with the pacemakers is a battery failure. These pacemakers use lithium-based batteries, which can form clusters of lithium and lead to battery failure. Obviously, these devices are central to the well-being of patients, so when they fail, the results can be severe.

Two deaths have already been reported due to the failure of St. Jude Medical pacemakers, in addition to dozens of patients who have suffered adverse effects. The recall covers roughly 200,000 pacemakers in the United States alone. One of the biggest concerns is that, while the failure of a pacemaker is hazardous, the procedure required to remove the device is also risky.

St. Jude Medical Was Slow to Act

Long before the Food and Drug Administration (FDA) issued the recall and St. Jude admitted to the true scope of the problem, physicians and teams at two reputable institutions – Duke University and the University of Illinois – found that St. Jude Medical pacemakers presented a battery failure risk. St. Jude, around this same period, fixed the flaw in new pacemakers, though they failed to act to alert the public or the medical community about the hazards of their old devices, according to the New York Times.

Reports suggest that St. Jude also failed to notify their own management and medical advisory board and likely downplayed the seriousness of the problem. This means that thousands of these devices were implanted in patients because St. Jude didn’t take proper action.

There are several lines of pacemakers covered by this recall, including the Fortify and Unify lines. A comprehensive list can be found on the FDA’s website.

The recall highlights a problem that we have seen repeatedly in the United States: A company sells a dangerous product to consumers, often knowing that it is hazardous, acting only after several complaints, injuries, and deaths are reported.

If you or a loved one believe that you have suffered harm due to the defective pacemaker made by St. Jude Medical, we encourage you to reach out to Terry Bryant Accident & Injury Law. Our product liability attorneys have years of experience handling cases involving defective products, and we offer free consultations to concerned consumers.

To schedule a free consultation with Terry Bryant Accident & Injury Law, contact us today by filling out our online contact form or giving us a call at 1 (800) 444-5000 or locally in the Houston area at (713) 973-8888.