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Latest Consumer News

• Class I Medical Device Recall: Abiomed, Inc., AB5000 Circulatory Support System - Reason for Recall: The computer may shut down (stop pumping) without an alarm. This defect may cause serious injuries or death.
• Class I Medical Device Recall: Baxter HomeChoice and HomeChoice PRO - Baxter is conducting a recall of the HomeChoice and HomeChoice PRO because of reports of serious injuries and at least one death associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
• Class I Medical Device Recall: Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath - These sheaths are used to pass heart catheters from the right to the left side of the heart by crossing the middle heart wall (septum).
• Class I Medical Device Recall: Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell - These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including...
• Class I Medical Device Recall: Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs) - These devices may not deliver therapy during a resuscitation attempt. Defects in certain electronic components may not be detected by the device?s Daily/Weekly/Monthly self-tests. These defects can cause improper functioning of the device during...
• Class I Medical Device Recall: StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #510 - Reason for Recall: The rotor of the centrifuge may break and separate from the motor, striking a safety microswitch so it fails to shut down the centrifuge. The loose rotor may strike the lid of the centrifuge housing which may cause the lid to open and..
• Class I Medical Device Recall: Thomas Medical Products Inc., Transseptal Sheath Introducer Kits - Reason for Recall: During heart procedures, the sheath tip may break off and separate while the sheath is in the blood vessels. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere...
• Consumer Information on: Thoratec HeartMate II® Left Ventricular Assist System (LVAS) - P060040S005 - The HeartMate II LVAS is a left ventricular assist device (LVAD) system, which is a device that helps the heart's left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body.

Archive for December, 2007

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