Urgent Penumbra Catheter Recall: Jet 7 Reperfusion Catheter

Product RecallAn urgent voluntary Penumbra catheter recall of the Jet 7 Reperfusion Catheter was issued on December 15, 2020, by Penumbra, Inc. due to a potentially disastrous defective condition. According to reports submitted to the FDA, the catheter has expanded, ballooned, and even fractured during thrombectomy–a procedure to remove blood clots in the brain.

Risks of the Product Failure

The Penumbra Jet 7 Reperfusion Catheter was designed as a tool to assist in the removal of blood clots in the brain. However, medical reports have indicated that sometimes the tool malfunctions resulting in the distal tip breaking off inside the patient’s blood vessel or the tip expanding and/or ballooning larger than the width of the containing vessel resulting in rupture.  These issues may result in severe bleeding on the brain, stroke, and even death.

Devices Recalled

The devices affected by the Penumbra catheter recall 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.

Unused Products

Medical professionals are instructed to cease using the catheters immediately and to remove them from their inventory so they do not get used. Instructions for returning unused products may be found here.  Physicians are also invited to reach out to their sales representatives for help or call Penumbra Customer Service at (888) 272-4606 for further assistance.

Injured by a Defective Catheter?

Simmons and Fletcher, P.C. Injury and Accident Lawyers are currently investigating claims related to defective Penumbra catheters. If you have been injured by a defective Penumbra catheter, talk to a Penumbra catheter lawsuit lawyer and your rights today. Defective product attorneys often offer a free consultation and charge no attorneys fees nor expenses unless a recovery is made.