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September's Top Stories: Multiple recalls | Doctor sues hospital | A warning from Abbott | Beta blockers 'have no effect'

News You Need to Know Today
September's Top Stories: Multiple recalls | Doctor sues hospital | A warning from Abbott | Beta blockers 'have no effect'
Thursday, October 2, 2025
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The Month in Review

Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 

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Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

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the words "FDA recall" on a board
More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 
READ MORE >

Cardiologist sues hospital after he was allegedly let go for sharing safety concerns

The veteran interventional cardiologist claims he was pushed out after repeatedly asking for more coverage from cardiothoracic surgeons in addition to other improvements. The hospital, meanwhile, described the lawsuit as a “collection of false allegations."

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A gavel and a stethoscope
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Cardiologist sues hospital after he was allegedly let go for sharing safety concerns

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A gavel and a stethoscope
The veteran interventional cardiologist claims he was pushed out after repeatedly asking for more coverage from cardiothoracic surgeons in addition to other improvements. The hospital, meanwhile, described the lawsuit as a “collection of false allegations."
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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 >

Seeing is believing: New cath lab technology takes coronary stent visualization to the next level

Sponsored by GE HealthCare

The technologies and tools of the cardiac catheterization lab have evolved in recent years, allowing interventionalists to perform procedures with more precision than ever. Angiographic imaging, meanwhile, has remained relatively consistent—but that is all starting to change.

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Seeing is believing: New cath lab technology takes coronary stent visualization to the next level

Sponsored by GE HealthCare

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ge_healthcare_3dstent_.png
The technologies and tools of the cardiac catheterization lab have evolved in recent years, allowing interventionalists to perform procedures with more precision than ever. Angiographic imaging, meanwhile, has remained relatively consistent—but that is all starting to change.
READ MORE >

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.

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The Dexcom G7 Continuous Glucose Monitoring System
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Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

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The Dexcom G7 Continuous Glucose Monitoring System
The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.
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Beta blockers ‘have no effect’ on heart attack patients

One researcher described the study's findings as "one of the most significant advances in heart attack treatment in decades.”

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Patient
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Beta blockers ‘have no effect’ on heart attack patients

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Patient
One researcher described the study's findings as "one of the most significant advances in heart attack treatment in decades.”
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Q&A: Cardiologist explores CMS proposal to cover cardiac ablations performed in ambulatory surgical centers

CMS has proposed a policy shift that would allow cardiac ablation procedures to be performed in ambulatory surgical centers. Arash Aryana, MD, PhD, a veteran cardiac electrophysiologist, explained why he is "extremely encouraged" by this proposal, highlighting several potential benefits. 

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Newsweek ranked the 50 best heart hospitals in the world
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Q&A: Cardiologist explores CMS proposal to cover cardiac ablations performed in ambulatory surgical centers

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Newsweek ranked the 50 best heart hospitals in the world
CMS has proposed a policy shift that would allow cardiac ablation procedures to be performed in ambulatory surgical centers. Arash Aryana, MD, PhD, a veteran cardiac electrophysiologist, explained why he is "extremely encouraged" by this proposal, highlighting several potential benefits. 
READ MORE >

America’s heart failure epidemic is getting worse

Approximately one in four Americans will develop heart failure in their lifetime, according to a new report from the Heart Failure Society of America. What can be done to combat this worrisome trend?

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America’s heart failure epidemic is getting worse

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heart data research doctor cardiologist AI
Approximately one in four Americans will develop heart failure in their lifetime, according to a new report from the Heart Failure Society of America. What can be done to combat this worrisome trend?
READ MORE >

FDA investigating Johnson & Johnson medical devices again after 5 injuries

To address this latest safety concern, the third in three months, the company is updating each device and then returning it to the customer.

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warning safety alert recall healthcare issue
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FDA investigating Johnson & Johnson medical devices again after 5 injuries

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warning safety alert recall healthcare issue
To address this latest safety concern, the third in three months, the company is updating each device and then returning it to the customer.
READ MORE >

Medtronic’s RDN system approved in Japan

Hypertension is a significant issue in Japan, impacting an estimated 43 million adults. Medtronic's Symplicity Spyral RDN system is now approved for the treatment of those patients. 

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Medtronic Symplicity Spyral renal denervation
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Medtronic’s RDN system approved in Japan

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Medtronic Symplicity Spyral renal denervation
Hypertension is a significant issue in Japan, impacting an estimated 43 million adults. Medtronic's Symplicity Spyral RDN system is now approved for the treatment of those patients. 
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