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:
- The JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
- The JET 7MAX configuration (such as the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.
However, this recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
Device Complications
There are many possible device complications such as:
- Device Rupture
- Ballooning
- Distal Tip Fracture
- Leakage
- Exposure of support coils
- Distal tip detachment
- Expansion of device
Associated Injuries
With device complications, the following are injuries that can occur from said complications:
- Blood Vessel Damage
- Hemorrhage
- Cerebral Infraction
- Stroke
- Brain Bleed
- Ruptured Arteries
- Death
Status of Litigation
Because we are in the early stages of the recall and the litigation, there is currently no state-issued MDL (Multi-district Litigation) currently.
Manufacturers
The current manufacturer for Jet 7 Stroke Catheter is Penumbra Inc.
