FDA details Class I recalls for more than 1 million pacemakers—software update required

The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.

Oct 13, 2025 - 20:00
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FDA details Class I recalls for more than 1 million pacemakers—software update required
The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.

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