MedWatch Safety Alerts

Title	Description	Pub Date
Boston Scientific Implantable Cardioverter Defibrillators: Recall	Practitioners should not use these devices unless and until FDA reviews and approves changes made by the manufacturer.	19-Mar-2010
Zocor (simvastatin): increased risk of muscle injury with high doses	Ongoing review shows risk also increased when drug, especially at higher doses, is used with certain drugs.	19-Mar-2010
Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall	Defective devices may result in air bubbles leaking into the infusion system and into the patient’s bloodstream.	18-Mar-2010
Cleviprex (clevidipine butyrate): Recall	The recall of 12/2009 has been expanded to include four additional lots. Presence of particulate matter which could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.	16-Mar-2010
Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall	Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized.	16-Mar-2010
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall	Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.	16-Mar-2010
Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug	Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers.	12-Mar-2010
Counterfeit Polypropylene Surgical Mesh: Initial Communication	Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.	12-Mar-2010
Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall	Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.	11-Mar-2010
Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures	FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.	11-Mar-2010