Medtronic—Talent Captivia Stent Graft Systems with FreeFlow Configuration: Potential for Difficulty in Releasing Proximal Bare Stent Using Tip Capture Mechanism
April 4, 2012 | Risk Management News
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FDA's Center for Devices and Radiological Health (CDRH) states that Medtronic has received reports related to the inability or difficulty releasing the proximal (FreeFlow) bare stent using the tip capture mechanism of the stent graft systems below. FDA's CDRH also states that the manufacturer initiated a recall...