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Latest Medical Device News

• Abiomed AB5000 Circulatory Support System: Class I Recall - Device computer may shut down without an alarm, which can lead to serious injuries or death.
• Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety - FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
• BD Q-Syte Luer Access Devices: Recall - Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
• Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall - Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
• Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall - UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
• Ear Candles: Risk of Serious Injuries - Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.
• Edwards Lifesciences Aquarius Hemodialysis System: Recall - Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.
• Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication - FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
• Exjade (deferasirox): Boxed Warning - Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
• Invirase (saquinavir): Ongoing safety review of clinical trial data - Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
• Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements - FDA requires risk management plan and class-labeling changes for all LABAs.
• Maalox Total Relief and Maalox Liquid Products: Medication Use Errors - Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.
• OneTouch SureStep Test Strips (LifeScan): Recall - Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
• Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical - Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
• StatSpin Express 4 Centrifuges Model 510: Class I Recall - Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
• Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: 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.
• Tysabri (Natalizumab): Update of Healthcare Professional Information - Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
• Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension - Risk information added to Warnings/Precautions section and data summary provided
• WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis - Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
• Zyprexa (olanzapine): Use in Adolescents - Clinicians should consider the potential long-term risks when prescribing to adolescents.

Archive for January, 2008

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