Boston Scientific to Update Pacemakers in Recall, FDA Says
By Kelly Cloonan
The Food and Drug Administration said Boston Scientific will upgrade certain pacemakers to a new software as part of a recall.
Boston Scientific issued a letter to affected customers recommending all of its Accolade pacemakers and cardiac resynchronization therapy pacemakers get upgraded to Brady SMR6 software, the FDA said. The correction aims to resolve risks that come with an earlier version of the software, including misinterpretation of test results in the presence of a magnet.
Boston Scientific also identified a potential risk that the old software could cause a prolonged voltage recovery state which may lead to a stuck battery status or diagnostics in some patients, the FDA said.
As of March 18, Boston Scientific has reported four deaths and 2,557 serious injuries associated with this issue, the FDA said.
"The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction," the agency said.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
May 07, 2026 19:20 ET (23:20 GMT)
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