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FDA warns public after patient death | Medtronic recalls heart devices | 'Compelling' new PE data | Pushing for TAVR changes

News You Need to Know Today
FDA warns public after patient death | Medtronic recalls heart devices | 'Compelling' new PE data | Pushing for TAVR changes
Friday, May 22, 2026
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Today's News and Trends

FDA warns public about Johnson & Johnson heart pump controllers after patient death

The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025. 

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The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025.
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FDA warns public about Johnson & Johnson heart pump controllers after patient death

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The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025.
The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025. 
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Medtronic recalls thousands of surgical devices due to contamination risk

This Class II recall includes more than 18,000 cannulae used during cardiac surgery.

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warning safety alert recall healthcare issue
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Medtronic recalls thousands of surgical devices due to contamination risk

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warning safety alert recall healthcare issue
This Class II recall includes more than 18,000 cannulae used during cardiac surgery.
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'Compelling' study shows promise of new pulmonary embolectomy system

"Pulmonary embolism is fundamentally a cardiovascular disease, where restoration of hemodynamic stability, beyond simple clot removal, is the key determinant of patient recovery,” one researcher explained. 

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Jupiter Endovascular's Vertex Pulmonary Embolectomy System showed positive results in its SPIRARE II pivotal trial.
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'Compelling' study shows promise of new pulmonary embolectomy system

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Jupiter Endovascular's Vertex Pulmonary Embolectomy System showed positive results in its SPIRARE II pivotal trial.
"Pulmonary embolism is fundamentally a cardiovascular disease, where restoration of hemodynamic stability, beyond simple clot removal, is the key determinant of patient recovery,” one researcher explained. 
READ MORE >

Advocacy group wants TAVR changes, urging Trump admin to ‘stop getting in between patients and their doctors’

The Alliance for Aging Research wants CMS to go through with policy changes that could make many more patients eligible for TAVR. The agency is currently considering the changes, and a final decision is expected in June. 

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
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Advocacy group wants TAVR changes, urging Trump admin to ‘stop getting in between patients and their doctors’

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
The Alliance for Aging Research wants CMS to go through with policy changes that could make many more patients eligible for TAVR. The agency is currently considering the changes, and a final decision is expected in June. 
READ MORE >

Featured Articles

Artivion acquires medtech company behind FDA-approved endovascular device for $135M

The purchase price could end up being closer to $200 million if certain commercial milestones are met.

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Nexus Aortic Arch System Artivion Endospan
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Artivion acquires medtech company behind FDA-approved endovascular device for $135M

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Nexus Aortic Arch System Artivion Endospan
The purchase price could end up being closer to $200 million if certain commercial milestones are met.
READ MORE >

Shockwave Medical's new IVL catheter overcomes previous limitations

Ziad Ali, MD, said the new device has completely changed the way he and his colleagues treat patients with calcified coronary artery disease. 

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Ziad Ali, MD, DPhil, director of the DeMatteis Cardiovascular Institute, St. Francis Hospital and Heart Center, spoke with Cardiovascular Business about his center's experience using the recently released Johnson & Johnson MedTech next-generation Shockwave C2 Aero Coronary IVL Catheter to treat calcified coronary artery disease. Ali said his center was the first in the world to use the catheter in August 2025 and has since gained experience in roughly 80 cases.
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Shockwave Medical's new IVL catheter overcomes previous limitations

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Ziad Ali, MD, DPhil, director of the DeMatteis Cardiovascular Institute, St. Francis Hospital and Heart Center, spoke with Cardiovascular Business about his center's experience using the recently released Johnson & Johnson MedTech next-generation Shockwave C2 Aero Coronary IVL Catheter to treat calcified coronary artery disease. Ali said his center was the first in the world to use the catheter in August 2025 and has since gained experience in roughly 80 cases.
Ziad Ali, MD, said the new device has completely changed the way he and his colleagues treat patients with calcified coronary artery disease. 
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SMART update: Self-expanding TAVR valves still linked to superior durability after 3 years

These three-year data represent a major update to one of the more noteworthy TAVR trials in recent memory.

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Medtronic Evolut FX TAVR valve. Medtronic has received an additional CE mark approval for its Evolut Pro+ and FX transcatheter aortic valve replacement (TAVR) valves; they can now be used for redo TAVR in addition to traditional TAVR procedures.
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SMART update: Self-expanding TAVR valves still linked to superior durability after 3 years

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Medtronic Evolut FX TAVR valve. Medtronic has received an additional CE mark approval for its Evolut Pro+ and FX transcatheter aortic valve replacement (TAVR) valves; they can now be used for redo TAVR in addition to traditional TAVR procedures.
These three-year data represent a major update to one of the more noteworthy TAVR trials in recent memory.
READ MORE >

In Case You Missed It

Doctors agree: There’s a lot to love about cardiology’s future

According to a new survey, both cardiologists and noncardiologists feel good about the specialty's long-term health. 

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Cardiologists employed by a hospital appear to be more likely to pursue cardiac catheterization or angioplasty than independent cardiologists. female physician male
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Doctors agree: There’s a lot to love about cardiology’s future

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Cardiologists employed by a hospital appear to be more likely to pursue cardiac catheterization or angioplasty than independent cardiologists. female physician male
According to a new survey, both cardiologists and noncardiologists feel good about the specialty's long-term health. 
READ MORE >

Heart Rhythm 2026: Electrophysiologist Mina Chung discusses CPR, PFA and much more

Mina Chung, MD, who just concluded a one-year term as Heart Rhythm Society's president, spoke to Cardiovascular Business about successes from the past year as well as her goals for the future.

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HRS President, Mina Chung, MD, FHRS, staff cardiologist and Professor of Medicine in the Section of Pacing and Electrophysiology, Heart & Vascular Institute, Cleveland Clinic. Explains HRS accomplishments in the past year in terms of advocacy efforts and policy concerns impacting EP. #HRS2026 #EPeeps
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Heart Rhythm 2026: Electrophysiologist Mina Chung discusses CPR, PFA and much more

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HRS President, Mina Chung, MD, FHRS, staff cardiologist and Professor of Medicine in the Section of Pacing and Electrophysiology, Heart & Vascular Institute, Cleveland Clinic. Explains HRS accomplishments in the past year in terms of advocacy efforts and policy concerns impacting EP. #HRS2026 #EPeeps
Mina Chung, MD, who just concluded a one-year term as Heart Rhythm Society's president, spoke to Cardiovascular Business about successes from the past year as well as her goals for the future.
READ MORE >

Johnson & Johnson to acquire Atraverse Medical

The move, once finalized, helps Johnson & Johnson add multiple FDA-approved technologies to its EP portfolio.

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healthcare business deal
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Johnson & Johnson to acquire Atraverse Medical

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healthcare business deal
The move, once finalized, helps Johnson & Johnson add multiple FDA-approved technologies to its EP portfolio.
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In Other News

5 points of light in the darkness of ‘healthcare’s moral emergency’

Western medicine often functions more like a high-tech patient-processing machine than a high-touch people-healing mission. This can and must change, argue three distinguished healthcare thought leaders. 

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points of light
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5 points of light in the darkness of ‘healthcare’s moral emergency’

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points of light
Western medicine often functions more like a high-tech patient-processing machine than a high-touch people-healing mission. This can and must change, argue three distinguished healthcare thought leaders. 
READ MORE >

America is clearly losing the war on drugs in some states, arguably winning in others

The state with the worst illicit drug problem is also home to the largest percentage of teenage users.

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drug bust drugs
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America is clearly losing the war on drugs in some states, arguably winning in others

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drug bust drugs
The state with the worst illicit drug problem is also home to the largest percentage of teenage users.
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