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- FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymakingJournal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…BioSpace · 12d ago↗ source
- Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer KitsProlonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation.fda medwatch · 12d ago↗ source
- Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro SystemAffected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.