Category Archives: Cardiology

Nitroglycerin in 5% Dextrose Injection by Baxter Recall

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Nitroglycerin in 5% Dextrose Injection by Baxter: Recall – Particulate Matter AUDIENCE: Risk Managers, Critical Care Medicine, Cardiology ISSUE: Baxter International Inc has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter … Continue reading

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Rosiglitazone containing Diabetes Medicines Drug Safety Communication

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Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication – Removal of Some Prescribing and Dispensing Restrictionsincluding Avandia, Avandamet, Avandaryl, and generics AUDIENCE: Family Care, Endocrinology, Cardiology ISSUE: FDA has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and … Continue reading

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Lexiscan regadenoson and Adenoscan adenosine Drug Safety Communication

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Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication – Rare but Serious Risk of Heart Attack and Death AUDIENCE: Cardiology, Pharmacy, Radiology ISSUE: The FDA is warning health care professionals of the rare but serious risk of heart attack and … Continue reading

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Medtronic Guidewires Recall

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Medtronic Guidewires: Recall – Potential For Coating On Surface To Delaminate And Detach AUDIENCE: Health Professional, Cardiology, Risk Management ISSUE: Medtronic, Inc.announced that FDA has classified the company’s recently initiated voluntary field action related to certain guidewire. Based on an internal … Continue reading

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Baylis Medical TorFlex Transseptal Guiding Sheath Kit Class I Recall

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Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall – Sheath Could Remove Particulate AUDIENCE: Cardiology, Risk Manager ISSUE:  FDA notified healthcare professionals of the Class 1 recall of TorFlex Transseptal Guiding Sheath Kit.  The sheath could remove particulate … Continue reading

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Low Molecular Weight Heparins Drug Safety Communication

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Low Molecular Weight Heparins: Drug Safety Communication – Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis AUDIENCE: Pharmacy, Cardiology, Anesthesiology ISSUE: The U.S. Food and Drug Administration (FDA) is recommending that health care professionals carefully consider the timing … Continue reading

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Edwards Lifesciences LLC EMBOL X Glide Protection System Class I Recall

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Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall – Deformed Cannula Tip AUDIENCE: Risk Manager, Cardiology ISSUE: FDA notified healthcare professionals that Edwards Lifesciences LLC issued a Class I Recall of the EMBOL-X Glide Protection System. The tip … Continue reading

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Bard LifeStent Solo Vascular Stent Class 1 Recall

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Bard LifeStent Solo Vascular Stent: Class 1 Recall – Failure to Deploy AUDIENCE: Cardio-vascular Surgery, Interventional Radiology ISSUE: FDA notified health professionals and medical care organizations of a class 1 recall of this product due to deployment issues that range … Continue reading

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St Jude Amplatzer Atrial Septal Occluder ASO Safety Communication

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St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication – Reports of Tissue Erosion AUDIENCE: Cardiology, Risk Manager, Patient ISSUE: FDA is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break … Continue reading

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Cordis Optease Retrievable Inferior Vena Cava IVC Filter Recall

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Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter: Recall – Labeling Correction AUDIENCE: Risk Manager, Cardiology, Surgery ISSUE: Cordis and FDA notified healthcare professionals and their organizations of a product labeling correction to provide clarification and additional information to minimize … Continue reading

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