A medical device, “AngioSculpt” percutaneous transluminal angioplasty (PTA) scoring balloon catheters made by AngioScore Inc. are being recalled.
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World-wide medical device company CareFusion announced on August 24 that the screens of their Alaris PC unit model 8015 occasionally received communication errors and froze on wireless networks. The Food and Drug Administration has now classified the recall as Class I, the most serious type of recall. The unit, intended to assist with patient therapy, once frozen would prevent changes in inputting treatment plans for patients. This could result in potentially serious issues with providing health care to patients. A (read more)
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