Penumbra JET 7 Stroke Catheters were recalled after 14 patients died of massive brain bleeding when the tip of the catheter ballooned outward or broke off.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Penumbra Jet 7 Stroke Catheter induced injury cases in all 50 states. If you or somebody you know was injured by a defective Penumbra catheter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: FDA Issues Class 1 Recall for Penumbra JET 7 Catheter Due to Tip Damage
On January 29, 2021, the FDA announced a Class 1 recall for all lots of Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology, also known as JET 7 Xtra Flex Catheters, due to reports of distal tip damage that have led to many serious injuries and deaths.
Approximately 30,882 devices were distributed globally between June 17, 2019 and December 14, 2020. Penumbra announced a JET 7 catheter recall on December 15, 2020.
Class 1 recalls are the most serious type of recall the FDA can issue, reserved for devices that are likely to cause severe injuries or deaths. According to the FDA warning:
“The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Twenty of these MDRs describe 14 unique patient deaths.”
Penumbra Jet 7 Catheters Recalled After 14 Deaths
In December 2020, Penumbra recalled JET 7 Xtra Flex Stroke Catheters after 14 deaths and over 200 injuries or malfunctions were reported.
What is the Problem?
Penumbra JET 7 catheters are used to remove blood clots in stroke patients. Unfortunately, there are numerous reports of the tip of the JET 7 catheter breaking off, or expanding like a balloon in the patient’s blood vessels, causing catastrophic brain bleeding and death.
The FDA adverse events include “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.”
What Is The Risk?
- Blood vessel damage
- Severe bleeding
- Cerebral infarction
What Catheters Are Being Recalled?
The FDA warning and recall includes the following Penumbra catheters:
- Jet 7 Xtra Flex Catheter
- Jet 7MAX configuration, which includes the Jet 7 Xtra Flex catheter and MAX Delivery Device
How Many Catheters Were Recalled?
The recall involves about 30,000 catheters in the U.S., including catheters that were FDA approved through the 510(k) program in June 2019 and February 2020. The 510(k) program allows new medical devices on the market without new clinical trials, so long as they are “substantially equivalent” to another device that is already approved.
Penumbra Issues Warnings Before the Recall
On July 27, 2020, Penumbra issued a Notification to Healthcare Providers, warning about the risk of serious injuries or deaths when the catheter was used to inject contrast media during procedures.
In August 2020, the FDA approved a new label update to warn doctors against using the device to inject contrast media.
Penumbra’s “Killer Catheter” — Was The Penumbra Catheter Rushed to Market?
In November 2020, Quintessential Capital Management (QCM) issued a report titled Penumbra and Its Killer Catheter — A Tale of Corporate Greed and Seemingly Blatant Disregard for Patients’ Lives.
The QCM report claimed that “Penumbra rushed to modify its Jet 7 Reperfusion Catheter device to compete with rivals” and that the “increased flexibility offered by the Jet 7 with Xtra Flex may have made it more prone to malfunction.”
On December 8, 2020, QCM published a follow-up report claiming that some of Penumbra’s “scientific research pieces appear to have been authored by a fake individual.” After this news was published, Penumbra’s share price fell $19.95 per share, or almost 9%.
Do I have a Penumbra Catheter Lawsuit?
The Schmidt Firm, PLLC is currently accepting Penumbra catheter induced injury cases in all 50 states. If you or somebody you know was injured by a defective Penumbra Jet 7 catheter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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