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The companies announced the initial recall because of the risk of valve failures, which could hinder the balloons from deflating and inflating. Read More
The UK’s Medicines and Healthcare products Regulatory Agency released final recommendations from the Mesh Oversight Group, which concluded hospitals need to improve their processes for tracking data and patients need to be better informed about potential risks of pelvic mesh devices. Read More
Boston Scientific sent out an alert when one of its pacemakers, the S-ICD device, “delivered an atypical amount of energy” after environmental radiation corrupted its memory, preventing S-ICD arrhythmia detection/treatment and ultimately causing the patient’s death. Read More
The FDA updated the status of a voluntary field removal notice for Penumbra’s 3D revascularization device, designating it as a Class I recall. Read More