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More than 1M pacemakers recalled | A safety warning from Abbott | Q&A: What cardiologists know and don’t know about PFA

News You Need to Know Today
More than 1M pacemakers recalled | A safety warning from Abbott | Q&A: What cardiologists know and don’t know about PFA
Friday, October 17, 2025
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Editor's Choice: Heart Rhythm

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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the words "FDA recall" on a board
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FDA details Class I recalls for more than 1 million pacemakers—software update required

Share on Twitter Share on Facebook Share on Linkedin
the words "FDA recall" on a board
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.
READ MORE >

Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients.
 

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Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.
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Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

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Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.
Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients. 
READ MORE >

Q&A: What cardiologists know and don’t know about pulsed field ablation

Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value. 

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Heart cardiologists doctors surgery
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Q&A: What cardiologists know and don’t know about pulsed field ablation

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Heart cardiologists doctors surgery
Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value. 
READ MORE >

Field Medical’s PFA system for ventricular tachycardia shows early potential

More research is still required, but Field Medical's FieldForce Ablation System may represent a significant step forward in the treatment of scar-related ventricular tachycardia.

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Field Medical's FieldForce pulsed field ablation system. Image courtesy of Field Medical.
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Field Medical’s PFA system for ventricular tachycardia shows early potential

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Field Medical's FieldForce pulsed field ablation system. Image courtesy of Field Medical.
More research is still required, but Field Medical's FieldForce Ablation System may represent a significant step forward in the treatment of scar-related ventricular tachycardia.
READ MORE >

FDA approves Zoll's newest defibrillator-monitor

The device, based on years of user feedback, is now cleared for use in both EMS and hospital settings.

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The U.S. Food and Drug Administration (FDA) granted pre-market approval (PMA) clearance for Zoll Zenix defibrillator-monitor for EMS and hospital use. It incorporates new technology and features based on years of user feedback.
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FDA approves Zoll's newest defibrillator-monitor

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The U.S. Food and Drug Administration (FDA) granted pre-market approval (PMA) clearance for Zoll Zenix defibrillator-monitor for EMS and hospital use. It incorporates new technology and features based on years of user feedback.
The device, based on years of user feedback, is now cleared for use in both EMS and hospital settings.
READ MORE >

Medtech companies working together on robotic PFA system

Stereotaxis and CardioFocus are collaborating on a new robotic pulsed field ablation system. After completing some initial research, the companies are now working toward the launch of a clinical trial. 

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Medtech companies working together on robotic PFA system

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Stereotaxis and CardioFocus are collaborating on a new robotic pulsed field ablation system. After completing some initial research, the companies are now working toward the launch of a clinical trial. 
READ MORE >

Virtual screens could make augmented reality more useful during cardiac ablation

It's still early, but a new feature could provide significant value when electrophysiologists use augmented reality during ablation procedures. 

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Sentiar CommandEP mixed reality system virtual screens augmented reality.
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Virtual screens could make augmented reality more useful during cardiac ablation

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Sentiar CommandEP mixed reality system virtual screens augmented reality.
It's still early, but a new feature could provide significant value when electrophysiologists use augmented reality during ablation procedures. 
READ MORE >

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