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Safety Mode Troubles Lead To Class I Recall For Boston Scientific’s Ingenio Pacemakers

 
• By Shawn M. Schmitt

The device giant recalled its Ingenio family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) because there’s a chance they can slip into safety mode, posing a risk to patients. It’s Boston Scientific’s fifth high-risk class I this year.

Boston Scientific sign.

A recall by Boston Scientific Corp. of its Ingenio heart devices has been labeled as high-risk class I by the US Food and Drug Administration.

The company recalled the Ingenio family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) on 3 June. The firm recalled...

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