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The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has identified this as a Class I recall, the most serious type of recall.
News | Cath Lab
Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

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The U.S. Food and Drug Administration (FDA) is alerting healthcare providers to the possibility that patients who have the Medtronic Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may have a welding defect in the internal pump causing the pump to malfunction.
News | Ventricular Assist Devices (VAD)
FDA Alert: Potential for Internal Pump Malfunction in the Medtronic HVAD System

April 28, 2022 — The U.S. Food and Drug Administration (FDA) is alerting healthcare providers to the possibility that ...

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Medtronic Harmony FDA recall The FDA has identified this as a Class I recall, the most serious type of recall
News | Heart Valve Technology
Medtronic Recalls Harmony Delivery Catheter, Part of TPV System, for Risk of Capsule Break During Use

April 27, 2022 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Medtronic Harmony ...

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Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
News | Heart Failure
Pfizer Issues Voluntary Nationwide Recall of ACCUPRIL (Quinapril HCl)

April 25, 2022 — Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer ...

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American Heart Association CEO Nancy Brown issued the following statement in response to the Senate confirmation of Robert M. Califf, M.D., as commissioner of the Food and Drug Administration (FDA)
News | Cardiovascular Business
Robert M. Califf, M.D., Confirmed to Lead FDA

February 15, 2022 — American Heart Association CEO Nancy Brown issued the following statement in response to the Senate ...

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President Joe Biden today announced his intention to nominate cardiologist Robert Califf, M.D., MACC, for the position of commissioner of food and drugs to lead the U.S. Food and Drug Administration (FDA). 
Feature | Cardiovascular Business| By Dave Fornell, DAIC Editor
President Biden Nominates Cardiologist Robert Califf for FDA Commissioner

November 12, 2021 — President Joe Biden today announced his intention to nominate cardiologist Robert Califf, M.D., MACC ...

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#breakingnews The U.S. Food and Drug Administration (FDA) just granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. It is the first vaccine to be fully approved by the FDA, and experts say it is expected to open the door for further vaccine mandates.
News | Coronavirus (COVID-19)
Pfizer-BioNTech COVID-19 Vaccine Gets Full Approval from FDA

August 23, 2021 — The U.S. Food and Drug Administration (FDA) just granted full approval to the Pfizer/BioNTech COVID-19 ...

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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 | Pacemakers
Boston Scientific Recalls INGENIO Family of Pacemakers

August 9, 2021 — Boston Scientific is recalling INGENIO family of pacemakers and CRT-Ps due to the risk of incorrect ...

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NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients
News | Heart Failure
VoluMetrix's NIVA|HF for Heart Failure Patients Designated as Breakthrough Device by U.S. FDA

June 15, 2021 — VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital ...

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The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects.
News | Heart Valve Technology
FDA Expands Approval of Replacement Heart Valve

The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used ...

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