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News You Need to Know Today
February's Top Stories: Multiple recalls | Statin labeling needs to be revised | A new device for AFib patients | TAVR vs. SAVR
Tuesday, March 3, 2026
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The Month in Review

FDA announces recall of Johnson & Johnson devices after multiple injuries, 1 death

Several detachable coil systems are being recalled due to a higher-than-expected failure to detach rate. Customers should not use them going forward.

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Cerepak Detachable Coil Systems
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FDA announces recall of Johnson & Johnson devices after multiple injuries, 1 death

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Cerepak Detachable Coil Systems
Several detachable coil systems are being recalled due to a higher-than-expected failure to detach rate. Customers should not use them going forward.
READ MORE >

Reprocessed EP catheters recalled due to contamination risk

The FDA has announced seven Class I recalls related to this issue. Customers are urged to destroy the devices immediately instead of returning them to the manufacturer. 

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Product Recall
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Reprocessed EP catheters recalled due to contamination risk

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Product Recall
The FDA has announced seven Class I recalls related to this issue. Customers are urged to destroy the devices immediately instead of returning them to the manufacturer. 
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FDA shares new warning about Johnson & Johnson heart pumps after 4 injuries

This represents the latest in a series of safety concerns associated with the Impella platform. The FDA said it is still reviewing the matter and will keep the public informed as new details become available. 

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warning safety alert recall healthcare issue
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FDA shares new warning about Johnson & Johnson heart pumps after 4 injuries

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warning safety alert recall healthcare issue
This represents the latest in a series of safety concerns associated with the Impella platform. The FDA said it is still reviewing the matter and will keep the public informed as new details become available. 
READ MORE >

Statin labeling should be revised with updated warnings, meta-analysis confirms

Researchers explored data from more than 123,000 patients, noting that dozens of the adverse complications included on current labels can safely be removed. 

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Continuous and high-adherent statin users had lower baseline arterial stiffness which also grew more slowly over time, a new JAMA Network Open study finds.
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Statin labeling should be revised with updated warnings, meta-analysis confirms

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Continuous and high-adherent statin users had lower baseline arterial stiffness which also grew more slowly over time, a new JAMA Network Open study finds.
Researchers explored data from more than 123,000 patients, noting that dozens of the adverse complications included on current labels can safely be removed. 
READ MORE >

Cardiologist develops new heart device that uses gel to reduce stroke risk in AFib patients

After years of implanting and studying LAAO devices, an interventional cardiologist with the University of Chicago has designed a new alternative that could reduce the risk of bleeding and save health systems money.

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After years of implanting left atrial appendage occlusion (LAAO) devices in atrial fibrillation (AFib) patients, an interventional cardiologist with the University of Chicago Medical Center (UChicago Medicine) has developed a new device that could be a more affordable alternative to Boston Scientific’s Watchman and Abbott’s Amplatzer Amulet LAA Occluder.
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Cardiologist develops new heart device that uses gel to reduce stroke risk in AFib patients

Share on Twitter Share on Facebook Share on Linkedin
After years of implanting left atrial appendage occlusion (LAAO) devices in atrial fibrillation (AFib) patients, an interventional cardiologist with the University of Chicago Medical Center (UChicago Medicine) has developed a new device that could be a more affordable alternative to Boston Scientific’s Watchman and Abbott’s Amplatzer Amulet LAA Occluder.
After years of implanting and studying LAAO devices, an interventional cardiologist with the University of Chicago has designed a new alternative that could reduce the risk of bleeding and save health systems money.
READ MORE >

Billionaire donates $50M to advance cardiovascular care at Northwestern

Neil G. Bluhm, a billionaire philanthropist with deep ties to Chicago, has donated an additional $50 million to a high-volume facility that already bears his name.

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Jane E Wilcox, MD, and Neil G. Bluhm. Image courtesy of Northwestern.
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Billionaire donates $50M to advance cardiovascular care at Northwestern

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Jane E Wilcox, MD, and Neil G. Bluhm. Image courtesy of Northwestern.
Neil G. Bluhm, a billionaire philanthropist with deep ties to Chicago, has donated an additional $50 million to a high-volume facility that already bears his name.
READ MORE >

TAVR linked to higher reintervention rate than SAVR in Evolut Low Risk trial update

The Evolut Low Risk trial has been one of cardiology’s most closely watched studies for years now. For the first five years after treatment, TAVR and SAVR were associated with comparable outcomes when treating low-risk patients. In this new six-year update, however, TAVR was linked to a heightened risk of reintervention not seen with SAVR. 

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Medtronic's Evolut Pro TAVR valve is designed to treat aortic stenosis.
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TAVR linked to higher reintervention rate than SAVR in Evolut Low Risk trial update

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Medtronic's Evolut Pro TAVR valve is designed to treat aortic stenosis.
The Evolut Low Risk trial has been one of cardiology’s most closely watched studies for years now. For the first five years after treatment, TAVR and SAVR were associated with comparable outcomes when treating low-risk patients. In this new six-year update, however, TAVR was linked to a heightened risk of reintervention not seen with SAVR. 
READ MORE >

ECG market keeps evolving thanks to AI, home monitoring and Epic integration

For years, the ECG market was relatively static. According to a new report, however, things are rapidly changing. 

READ MORE >
The HeartBeam AIMIGo device is approximately the size of a credit card and uses the company’s patented 3D vectorelectrocardiography (3D VECG) technology to capture signals from three different projections and deliver a synthesized 12-lead ECG.
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ECG market keeps evolving thanks to AI, home monitoring and Epic integration

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The HeartBeam AIMIGo device is approximately the size of a credit card and uses the company’s patented 3D vectorelectrocardiography (3D VECG) technology to capture signals from three different projections and deliver a synthesized 12-lead ECG.
For years, the ECG market was relatively static. According to a new report, however, things are rapidly changing. 
READ MORE >

It’s about to get harder for many Medicare patients to see a cardiologist

UnitedHealthcare now requires patients enrolled in certain Medicare Advantage plans to receive a PCP referral before seeing a cardiologist. On May 1, the insurer will start denying all claims that do not include the necessary referral. UnitedHealthcare argues that "stronger PCP engagement" is good for patient care, but many stakeholders disagree.

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Referral
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It’s about to get harder for many Medicare patients to see a cardiologist

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Referral
UnitedHealthcare now requires patients enrolled in certain Medicare Advantage plans to receive a PCP referral before seeing a cardiologist. On May 1, the insurer will start denying all claims that do not include the necessary referral. UnitedHealthcare argues that "stronger PCP engagement" is good for patient care, but many stakeholders disagree.
READ MORE >

Cardiologist discusses Lp(a), the CVD risk factor responsible for many surprise heart attacks

Cardiologist Nathaniel Lebowitz, MD, reviews the latest updates in lipoprotein(a) awareness, testing and drug development.

READ MORE >
Nathaniel Lebowitz, MD, in charge of preventive cardiology at Hackensack University Medical Center, and assistant professor of internal medicine at Hackensack Meridian School of Medicine, gives an overview of where things are at with lipoprotein (a) awareness, testing and drug development. He and is working on the American Heart Associations (AHA) Lp(a) Discovery Project to expand awareness to both physicians and patients. #AHA #LPA
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Cardiologist discusses Lp(a), the CVD risk factor responsible for many surprise heart attacks

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Nathaniel Lebowitz, MD, in charge of preventive cardiology at Hackensack University Medical Center, and assistant professor of internal medicine at Hackensack Meridian School of Medicine, gives an overview of where things are at with lipoprotein (a) awareness, testing and drug development. He and is working on the American Heart Associations (AHA) Lp(a) Discovery Project to expand awareness to both physicians and patients. #AHA #LPA
Cardiologist Nathaniel Lebowitz, MD, reviews the latest updates in lipoprotein(a) awareness, testing and drug development.
READ MORE >

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