Author Archives: Anthony Cirurgiao

Rapid data response to avoid further patient harm

The recent recall of the Penumbra JET™ 7 reperfusion catheter came after 200 adverse events (AEs), including 14 patient deaths. The Class I device is intended to remove blood clots in the brain that cause stroke. The version of the product the FDA approved in 2019 was nearly 20 years in the making across incremental changes to several related products. … Read More