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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

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More from Policy & Regulation

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• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

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