In December 2020, the U.S. FDA issued an alert that Penumbra has urgently recalled their device, the Jet 7 Stroke Catheter following multiple reports of issues from patients. This voluntary recall is based on the risk of serious injuries, or death, while being used in patients. The device has been on the market since February 2020.
Furthermore, the FDA has received over 200 adverse medical device reports regarding the Jet 7 Stroke Catheter reporting deaths, serious injuries, and device complications. The recalled models include the following:
However, this recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
There are many possible device complications such as:
With device complications, the following are injuries that can occur from said complications:
Because we are in the early stages of the recall and the litigation, there is currently no state-issued MDL (Multi-district Litigation) currently.
The current manufacturer for Jet 7 Stroke Catheter is Penumbra Inc.