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August's Top Stories: A new Watchman risk | Device recalls | Cardiologist to pay $1.2M | PFA & nerve damage | LAAO guidelines

News You Need to Know Today
August's Top Stories: A new Watchman risk | Device recalls | Cardiologist to pay $1.2M | PFA & nerve damage | LAAO guidelines
Monday, September 1, 2025
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The Month in Review

FDA says Watchman access systems may increase risk of air embolism—17 deaths reported

Because of this risk, which has been associated with 120 serious injuries, Boston Scientific is updating the instructions for use of several Watchman access systems.

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Watchman TruSteer Access System
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FDA says Watchman access systems may increase risk of air embolism—17 deaths reported

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Watchman TruSteer Access System
Because of this risk, which has been associated with 120 serious injuries, Boston Scientific is updating the instructions for use of several Watchman access systems.
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. 

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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 >

FDA announces new recall of reprocessed EP catheters due to risk of contamination

Customers with these devices on hand are asked to return them right away. No serious injuries have been reported at this time, but the presence of residual particulates can lead to such side effects as pulmonary embolism and deep vein thrombosis.

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Reprocessed Supreme Fixed Electrophysiology Catheter
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FDA announces new recall of reprocessed EP catheters due to risk of contamination

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Reprocessed Supreme Fixed Electrophysiology Catheter
Customers with these devices on hand are asked to return them right away. No serious injuries have been reported at this time, but the presence of residual particulates can lead to such side effects as pulmonary embolism and deep vein thrombosis.
READ MORE >

Texas cardiologist to pay $1.2M for allegedly prescribing opioids to himself

The interventional cardiologist was accused of prescribing a variety of drugs to his family and friends, but then picking them up himself for his own personal use. This settlement officially resolves those allegations. 

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pain pills opioids
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Texas cardiologist to pay $1.2M for allegedly prescribing opioids to himself

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pain pills opioids
The interventional cardiologist was accused of prescribing a variety of drugs to his family and friends, but then picking them up himself for his own personal use. This settlement officially resolves those allegations. 
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 >

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 >

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 >

PFA linked to increased risk of phrenic nerve damage

“We believe that any iatrogenic complication should be reported,” the study's authors wrote. “No patient expects to be discharged from hospital with a new diaphragmatic deficit without being informed."

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The Farapulse Boston Scientific Pulsed Field Ablation (PFA) system gained U.S. FDA approval in early 2024.
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PFA linked to increased risk of phrenic nerve damage

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The Farapulse Boston Scientific Pulsed Field Ablation (PFA) system gained U.S. FDA approval in early 2024.
“We believe that any iatrogenic complication should be reported,” the study's authors wrote. “No patient expects to be discharged from hospital with a new diaphragmatic deficit without being informed."
READ MORE >

Heart surgeon performs first robotic aortic valve replacement of its kind

The minimally invasive operation, known as AVATAR, is performed through a small incision in the patient’s neck.

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Corcym’s Perceval Plus aortic heart valve
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Heart surgeon performs first robotic aortic valve replacement of its kind

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Corcym’s Perceval Plus aortic heart valve
The minimally invasive operation, known as AVATAR, is performed through a small incision in the patient’s neck.
READ MORE >

New LAAO guidelines: 6 key takeaways for interventional cardiologists and electrophysiologists

SCAI and HRS have collaborated on new guidelines designed to help clinicians make the safest, smartest treatment decisions possible.

READ MORE >
Newsweek ranked the 50 best heart hospitals in the world
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New LAAO guidelines: 6 key takeaways for interventional cardiologists and electrophysiologists

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Newsweek ranked the 50 best heart hospitals in the world
SCAI and HRS have collaborated on new guidelines designed to help clinicians make the safest, smartest treatment decisions possible.
READ MORE >

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