The recall, categorized as the most serious type by the FDA, does not remove the product from the market but updates its use instructions, according to a Feb. 28 news release from the agency. The updated guidance emphasized adherence to recommended use parameters to mitigate the risk.
The change follows an evaluation in which 4 of 132 patients (3%), experienced strokes or transient ischemic attacks, a rate that is higher than the expected 1% for similar procedures.
Healthcare providers are advised to review the new instructions, assess risks with any new patients and continue to monitor those who have undergone procedures with the device. Johnson & Johnson also paused further evaluations and plans a post-approval study.
There have been four serious injuries reported and no deaths.