PENUMBRA JET 7 STROKE CATHETER LAWSUIT WHITEPAPER

About Penumbra Catheter Lawsuit

In December 2020, the U.S. FDA issued an alert that Penumbra urgently recalled their device, the Jet 7 Stroke Catheter. 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.

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 JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
• The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.

This recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.

Penumbra Catheter Device Complications

• Device Rupture
• Ballooning
• Distal Tip Fracture
• Leakage
• Exposure of support coils
• Distal tip detachment
• Expansion of device

Penumbra Catheter Associated Injuries

• Blood Vessel Damage
• Hemorrhage
• Cerebral Infraction
• Stroke
• Brain Bleed
• Ruptured Arteries
• Death

Penumbra Catheter 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.

Penumbra Catheter Manufacturers

The current manufacturer for Jet 7 Stroke Catheter is Penumbra Inc.