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Stryker is recalling its Fuhrman pleural and pneumopericardial drainage set because of the potential for the device’s catheter to break during insertion. Read More
The FDA has alerted Puerto Rican healthcare providers and facilities not to use Customed’s convenience packs and trays for surgical procedures. Read More
A lack of documented testing of updated instructions for use for cleaning a heater-cooler system has helped earn LivaNova an FDA warning letter. Read More
Following a rash of infections related to duodenoscopes, the FDA has given its blessing to Fujifilm Medical Systems’ updated manual reprocessing instructions for its ED-530XT model. Read More
The FDA has taken device manufacturer Moss Tubes to task over multiple alleged reporting violations tied to product failures, one of which apparently resulted in a patient death. Read More
Abbott is recommending that physicians who implant the MitraClip Delivery System receive training following reports of users being unable to separate the implantable clip from the delivery system. Read More
The FDA has hit a developer of a system designed to help patients walk with a warning letter for failing to provide timely updates to its postmarket surveillance plans. Read More