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News You Need to Know Today
A new warning for cath labs | The push for better safety standards | Major recalls | FDA clears next-gen imaging system
Wednesday, April 22, 2026
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Editor's Choice: Policy & Regulations

FDA shares warning about cath lab procedure kits due to risk of patient injury

The syringes included in several convenience kits should not be used due to a safety risk linked to multiple injuries.

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Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination.  Surgeons Operating On Patient
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FDA shares warning about cath lab procedure kits due to risk of patient injury

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Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination.  Surgeons Operating On Patient
The syringes included in several convenience kits should not be used due to a safety risk linked to multiple injuries.
READ MORE >

Weight loss pill linked to reduced risk of heart attack or stroke after FDA requested more data

The FDA asked, and Eli Lilly and Company delivered. The company now hopes to secure an additional approval for orforglipron/Foundayo that covers the treatment of type 2 diabetes.

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orforglipron Foundayo Eli Lilly
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Weight loss pill linked to reduced risk of heart attack or stroke after FDA requested more data

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orforglipron Foundayo Eli Lilly
The FDA asked, and Eli Lilly and Company delivered. The company now hopes to secure an additional approval for orforglipron/Foundayo that covers the treatment of type 2 diabetes.
READ MORE >

Cardiologists lead push for new cath lab radiation safety standards

Several U.S. medical societies have collaborated on a new report advocating for better safety standards in cardiac catheterization labs. As one cardiologist described it, clinicians have shifted from "accepting risk" to "expecting better."

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Heart doctors and surgeons working together. Top cardiology hospitals in the United States.
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Cardiologists lead push for new cath lab radiation safety standards

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Heart doctors and surgeons working together. Top cardiology hospitals in the United States.
Several U.S. medical societies have collaborated on a new report advocating for better safety standards in cardiac catheterization labs. As one cardiologist described it, clinicians have shifted from "accepting risk" to "expecting better."
READ MORE >

FDA approves smallest defibrillation lead of its kind for LBBA placement

The OmniaSecure defibrillation lead from Medtronic is already approved for placement in the right ventricle. This latest approval covers the left bundle branch area, opening the door for conduction system pacing and other advanced techniques.

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OmniaSecure defibrillation lead approved by FDA for placement in LBB area
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FDA approves smallest defibrillation lead of its kind for LBBA placement

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OmniaSecure defibrillation lead approved by FDA for placement in LBB area
The OmniaSecure defibrillation lead from Medtronic is already approved for placement in the right ventricle. This latest approval covers the left bundle branch area, opening the door for conduction system pacing and other advanced techniques.
READ MORE >

FDA warns that certain sizing catheters should not be used due to risk of breaking

These catheters from Cook Medical are associated with an increased risk of device fragmentation or vessel injury. Customers are urged to return them to the manufacturer. 

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Beacon Tip Centimeter Sizing Catheter FDA alert
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FDA warns that certain sizing catheters should not be used due to risk of breaking

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Beacon Tip Centimeter Sizing Catheter FDA alert
These catheters from Cook Medical are associated with an increased risk of device fragmentation or vessel injury. Customers are urged to return them to the manufacturer. 
READ MORE >

Medline recalls millions of devices due to safety risk—FDA threatens ‘regulatory action’ in warning letter

Millions of angiographic syringes were recalled due to a risk of parts becoming loose or disconnected. The FDA, unhappy with Medline's response to this situation, sent the company a new warning letter. 

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warning safety alert recall healthcare issue
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Medline recalls millions of devices due to safety risk—FDA threatens ‘regulatory action’ in warning letter

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warning safety alert recall healthcare issue
Millions of angiographic syringes were recalled due to a risk of parts becoming loose or disconnected. The FDA, unhappy with Medline's response to this situation, sent the company a new warning letter. 
READ MORE >

FDA confirms another recall for Johnson & Johnson’s Impella heart pumps

More than 33,000 devices are affected by this recall. Customers may need to return and replace the purge cassettes included with their devices due to a risk of serious injury or death. 

READ MORE >
Recall | Product recall
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FDA confirms another recall for Johnson & Johnson’s Impella heart pumps

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Recall | Product recall
More than 33,000 devices are affected by this recall. Customers may need to return and replace the purge cassettes included with their devices due to a risk of serious injury or death. 
READ MORE >

Software errors lead to major insulin pump recall—manufacturer shares a fix

Nearly 27,000 MiniMed 780G insulin pumps were included in a new Class II recall. By taking a few basic steps, however, patients should be able to avoid any significant risks.

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Medtronic’s MiniMed 780G automated insulin delivery system
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Software errors lead to major insulin pump recall—manufacturer shares a fix

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Medtronic’s MiniMed 780G automated insulin delivery system
Nearly 27,000 MiniMed 780G insulin pumps were included in a new Class II recall. By taking a few basic steps, however, patients should be able to avoid any significant risks.
READ MORE >

FDA clears next-gen hybrid system for intravascular imaging

Conavi Medical's new hybrid imaging system simultaneously performs IVUS and OCT.

READ MORE >
CMS greenlights LDCT lung cancer screening
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FDA clears next-gen hybrid system for intravascular imaging

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CMS greenlights LDCT lung cancer screening
Conavi Medical's new hybrid imaging system simultaneously performs IVUS and OCT.
READ MORE >

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