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Latest innovation has the potential to reduce anesthesia during minimally invasive procedures
News | Transesophageal Echo (TEE)
New Philips Mini TEE Ultrasound Transducer Helps Improve Cardiac Care for More Patients

January 31, 2024 — Royal Philips, a global leader in health technology, announced that its latest TEE transducer ...

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The U.S. Food and Drug Administration (FDA) has issued a Letter to Health Care Providers about updated information associated with paclitaxel-coated devices used to treat peripheral arterial disease (PAD)
News | Peripheral Artery Disease (PAD)
Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality

July 11, 2023 — The U.S. Food and Drug Administration (FDA) is informing healthcare providers about updated information ...

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The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death
News | Catheter
Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect

January 31, 2023 — The U.S. Food and Drug Administration (FDA) issued a statement announcing that Medtronic is recalling ...

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Medtronic conducted a recall to inform health care providers and patients of battery performance issues.
News | Ventricular Assist Devices (VAD)
FDA Provides Update on Medtronic's HeartWare Ventricular Assist Device (HVAD) System

October 18, 2022 — The U.S. Food and Drug Administration (FDA) is providing updates to the FDA website to include ...

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The U.S. Food and Drug Administration (FDA) is alerting healthcare providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott.
News | Heart Valve Technology
FDA Alerts Healthcare Providers to Potential for Clip Lock Malfunctions in Abbott MitraClip Device

September 9, 2022 — The U.S. Food and Drug Administration (FDA) is alerting healthcare providers about potential clip ...

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According to a release just issued by the U.S. Food and Drug Administration (FDA), Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after receiving reports that some devices have triggered short circuit protection (SCP) alerts during the second phase of high voltage waveform therapy and delivered reduced-energy electric shocks.
News | Implantable Cardioverter Defibrillator (ICD)
Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy

August 19, 2022 — According to a release just issued by the U.S. Food and Drug Administration (FDA), Medtronic is ...

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the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch Ventricular Restoration System
News | Heart Failure
Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System

July 13, 2022 — Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today ...

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Medtronic, Inc. is recalling a single lot of HeartWare HVAD System batteries due to welding defects that allow separation of the two cell battery packs used to power the system
News | Ventricular Assist Devices (VAD)
Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure

June 23, 2022 — Medtronic, Inc. is recalling a single lot of HeartWare HVAD System batteries due to welding defects that ...

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The U.S. Food and Drug Administration (FDA) has issued a release stating that Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect.
News | Ventricular Assist Devices (VAD)
Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

June 8, 2022 — The U.S. Food and Drug Administration (FDA) has issued a release stating that Medtronic is recalling the ...

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
News | Stents
FDA Class 1 Recall on iCast Stent for Separation Risk That May Cause Harm

June 2, 2022 — According to the U.S. Food and Drug Administration (FDA), Atrium Medical Corporation is recalling the ...

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