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On Oct. 10, Boston Scientific sent an urgent medical device advisory to all affected customers with recommendations. FDA classifies recall of Boston Scientific catheters as 'most serious' Skip to ...
An investigation showed that Boston's device, Obsidio Embolic, when used with a specific technique posed a higher risk of bowel ischemia during procedures to stop gastrointestinal (GI) bleeding ...
Learn more about the AOL app and download it from Google Play. The AOL app is available for Android devices running Android 9.0 or newer. Open the Google Play Store on your device. Type "AOL" in the search field. Choose AOL - News, Mail & Video from the search results. Tap Install. Tap Open. If you're unable to update the AOL app, use the ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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Boston Scientific Corporation (BSC), headquartered in Marlborough, Massachusetts and incorporated in Delaware, [2] is an American biotechnology and biomedical engineering firm and multinational manufacturer of medical devices used in interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular ...
Product recalls are one of a number of corrective actions that can be taken for products that are deemed to be unsafe. The recall is an effort to limit ruination of the corporate image and limit liability for corporate negligence, which can cause significant legal costs. It can be difficult, if not impossible, to determine how costly can be ...
The FDA has issued a statement following the Class I recall for an IOS app used in conjunction with insulin pumps after 224 injuries were reported.