Although St. Jude Medical recalled certain implantable cardioverter defibrillators in 2015, the company acknowledged that it had continued to ship the old devices for up to 17 months, the Minneapolis Star Tribune reports.
The newspaper noted that there have been two confirmed cases of patients dying when the batteries in the devices faltered and led to the devices not administering lifesaving shocks.
After the recall, St. Jude Medical changed the battery design but continued to sell its stock of older units, according to the newspaper. The recall affected models of the company’s Fortify, Unify and Assura devices.
St. Jude Medical executives told the Star Tribune that they did not know when they changed the battery design that the recall would affect 350,000 implanted devices.
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Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.