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News You Need to Know Today
Stents recalled | New hypertension guidelines | RDN tech gains key approvals | Insulin pump error linked to 700 adverse events
Friday, September 5, 2025
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Editor's Choice: Policy & Regulations

FDA announces new recall of self-expanding stents due to risk of ‘serious harm’

The Class I recall includes more than 26,000 vascular stents from Boston Scientific. These devices have been linked to a risk of potential resistance when the stent delivery system is being withdrawn. 

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Product Recall
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FDA announces new recall of self-expanding stents due to risk of ‘serious harm’

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Product Recall
The Class I recall includes more than 26,000 vascular stents from Boston Scientific. These devices have been linked to a risk of potential resistance when the stent delivery system is being withdrawn. 
READ MORE >

New hypertension guidelines embrace early treatment, updated risk assessments and renal denervation

New ACC/AHA recommendations encourage clinicians to take a proactive approach when managing patients with elevated or high blood pressure. The inclusion of renal denervation in this document represents clear progress for a relatively new technology.

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cardiologist doctor physician patient black diverse hypertension
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New hypertension guidelines embrace early treatment, updated risk assessments and renal denervation

Share on Twitter Share on Facebook Share on Linkedin
cardiologist doctor physician patient black diverse hypertension
New ACC/AHA recommendations encourage clinicians to take a proactive approach when managing patients with elevated or high blood pressure. The inclusion of renal denervation in this document represents clear progress for a relatively new technology.
READ MORE >

How economic forces are reshaping the future of cardiac care

Karen Joynt Maddox, MD, MPH, explained the many ways cardiology's business models are starting to evolve. She also touched on a number of other topics, including AI and the power of prevention.

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Karen Joynt Maddox discusses macroeconomic factors pressuring traditional models of cardiac care.
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How economic forces are reshaping the future of cardiac care

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Karen Joynt Maddox discusses macroeconomic factors pressuring traditional models of cardiac care.
Karen Joynt Maddox, MD, MPH, explained the many ways cardiology's business models are starting to evolve. She also touched on a number of other topics, including AI and the power of prevention.
READ MORE >

Recor Medical gains historic approval for its ultrasound RDN system

Recor Medical's Paradise Ultrasound Renal Denervation System is the first medical device approved for the treatment of hypertension in Japan. It first gained FDA approval back in 2023.

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The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.
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Recor Medical gains historic approval for its ultrasound RDN system

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The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.
Recor Medical's Paradise Ultrasound Renal Denervation System is the first medical device approved for the treatment of hypertension in Japan. It first gained FDA approval back in 2023.
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. 
READ MORE >

FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.

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Johnson & Johnson MedTech Automated Impella Controller
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FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

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Johnson & Johnson MedTech Automated Impella Controller
This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.
READ MORE >

Insulin pump error linked to 700 adverse events

Speaker issues are causing the devices to stop communicating with the user's CGM. Dozens of patient injuries have been reported, and the company is prepping a software update.

READ MORE >
Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.
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Insulin pump error linked to 700 adverse events

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Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.
Speaker issues are causing the devices to stop communicating with the user's CGM. Dozens of patient injuries have been reported, and the company is prepping a software update.
READ MORE >

FDA shares new safety concern with Medtronic catheters—warns of possible shortage in months ahead

The FDA has received multiple reports of the devices, which are designed to be malleable, failing to retain their shape. The issue has been linked to three patient injuries so far, and customers are asked to return unused devices to the manufacturer. 

READ MORE >
warning safety alert recall healthcare issue
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FDA shares new safety concern with Medtronic catheters—warns of possible shortage in months ahead

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warning safety alert recall healthcare issue
The FDA has received multiple reports of the devices, which are designed to be malleable, failing to retain their shape. The issue has been linked to three patient injuries so far, and customers are asked to return unused devices to the manufacturer. 
READ MORE >

Abbott’s dissolving stent picks up a key approval

It's another big victory for Abbott's bioresorbable stent for BTK PAD. 

READ MORE >
The Abbott Esprit BTK everolimus-eluting biosorbable scaffold system for below the knee peripheral artery disease on display at TCT 2024. Photo by Dave FornellTCTn 2024 DF
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Abbott’s dissolving stent picks up a key approval

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The Abbott Esprit BTK everolimus-eluting biosorbable scaffold system for below the knee peripheral artery disease on display at TCT 2024. Photo by Dave FornellTCTn 2024 DF
It's another big victory for Abbott's bioresorbable stent for BTK PAD. 
READ MORE >

FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

Boston Scientific manufactured these devices from 2002 to 2021, and approximately 354,000 are still in use. It is recommended that clinicians look for early signs of this issue during scheduled follow-up appointments.

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U.S. FDA Sign
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FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

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U.S. FDA Sign
Boston Scientific manufactured these devices from 2002 to 2021, and approximately 354,000 are still in use. It is recommended that clinicians look for early signs of this issue during scheduled follow-up appointments.
READ MORE >

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