Boston Scientific to Update Pacemakers Under FDA Recall

Deep News
May 08

The U.S. Food and Drug Administration has announced that Boston Scientific will perform software upgrades on certain pacemakers as part of a recall. According to the FDA, Boston Scientific has notified affected customers and recommended upgrading all Accolade and cardiac resynchronization therapy pacemakers to Brady SMR6 software. The update is intended to address risks associated with older software versions, including the potential for misinterpretation of test results when a magnet is present. Boston Scientific also identified a potential risk where the older software could cause prolonged voltage recovery, which may lead to battery status issues or diagnostic errors in some patients. As of March 18, Boston Scientific has reported four deaths and 2,557 serious injuries related to the issue. The FDA stated, "This recall has been classified as the most serious type. Failure to implement the correction and continued use of the device may result in serious injury or death."

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