Covidien Initiates Aneurysm Device Recall
This article was originally published in The Gray Sheet
The voluntary recall of Covidien’s Pipeline aneurysm embolization device and Alligator retrieval devices is expected to have a slight negative effect on earnings in the second half of the year, but the impact could increase if it takes longer than expected to replace the affected products, the firm suggested.
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The firm hopes to support approval for use of the embolization device for smaller aneurysms and in more anatomical locations with data from its just-launched PREMIER trial. Also, Covidien announced the first patient in a new registry to track postmarket data, and hopefully support reimbursement, for its mechanical thrombectomy stroke devices including Solitaire 2.
FDA tagged Covidien’s April 1 recall of its Pipeline aneurysm embolization devices and Alligator retrieval devices as a high risk, class I action.
Covidien’s Pipeline gains PMA approval