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The FDA says there have been 55 reported injuries, but no deaths, due to the tip breaking off or separating during use.
Source: TCTMD.comCategories: Cardiology News and Journals, Latest HeadlinesTweet
The FDA says there have been 55 reported injuries, but no deaths, due to the tip breaking off or separating during use.
The @US_FDA has issued a #ClassIRecall for HawkOne Directional Atherectomy Systems, citing a risk of the guidewire prolapsing when pressure is applied. This can cause the tip to break off or separate from the device. https://t.co/GP2NmvZSNf