Source:

Press Release

April 23, 2021
1 min read
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FDA designates recall of Cordis carotid system as class 1

Source:

Press Release

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The FDA has identified a recall by Cordis Corporation of the Precise PRO Rx US Carotid System as class I due to defects that may cause serious adverse events, according to a press release.

The device, which is designed for patients with narrowed carotid arteries, is being recalled for separation of the atraumatic distal tip of the sheathed delivery system in patients. If, during use, the device separates, this defect could lead to distal embolization, stroke or removal of the separated tip from the carotid artery, according to the release.

Overall, Cordis is recalling 7,300 devices which were manufactured October 2019 through August 2020 and distributed in the United States from Dec. 6, 2019 to Feb. 8, 2021. There have been seven reported complaints about this issue with the device with five reported injuries and no deaths.

Cordis commenced the recall on Feb. 11, 2021 when it sent a letter about the problem and instructions about what to do to all affected customers, according to the release.