Penumbra (NYSE:PEN) has issued an urgent voluntary recall of all configurations of its Jet 7 Reperfusion Catheters with Xtra Flex Technology because the catheter may become susceptible to distal tip damage during use.
So far, Alameda, Calif.-based Penumbra has received 14 reports of death related to the problem out of the more than 30,000 distributed units. The device poses the risk of unexpected death or serious injury while used for removing clots in stroke patients. Distal tip damage with pressurization or contrast injection could result in potential vessel damage and patient injury or death.
The FDA has received over 200 medical device reports associated with the catheter, which includes deaths, serious injuries and malfunctions, according to the FDA letter warning health providers. The FDA said 20 of the MDRs describe 14 unique patient deaths, including reports from different reporting sources for a single adverse event, related to distal tip damage. This includes damage related to expansion or rupture following contrast injection. The company is also aware of 17 unique events involving patient injury.
“For more than 16 years, we have produced products with a singular mission of improving health outcomes for people suffering from strokes and other serious conditions. Throughout this history, we have been clear that we will never settle for anything less than complete confidence in the safety of our products. Our team has worked tirelessly to ensure the highest standards for the Penumbra Jet 7 Xtra Flex. Despite efforts to take steps to ensure the safe use of the product, including updating its instructions for use, we have issued a voluntary recall,” a spokesperson for Penumbra told Medical Tubing + Extrusion in an email. “We are deeply saddened by the deaths and injuries, and we thank the FDA for their partnership in ensuring that every product we bring to market is held to the highest of standards. We remain inspired by what the combination of talented physicians and cutting-edge technology can do to improve health outcomes for patients, and we look forward to playing a role when it comes to improving care for those suffering from stroke and other serious conditions.”
Penumbra said it hasn’t received any reports of deaths with the device since late-October, which led to the company requesting the urgent voluntary recall.
“We are deeply saddened by these tragic events,” president and CEO Adam Elsesser said during an investor call.
Other MDRs reported patient injuries such as vessel damage, hemorrhage and cerebral infarction. The device failure modes reported 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, according to the FDA warning letter.
The voluntary recall follows the company’s notification to healthcare providers about the device on July 27. Penumbra said all users should stop using the Jet 7 Xtra Flex catheter and remove and quarantine all unused affected products in their inventories. The company also recommended returning the affected products to Penumbra in accordance with the company’s instructions.
Penumbra’s Jet 7 Xtra Flex catheter and Jet 7 Max configuration (Jet 7 Xtra Flex catheter and Max delivery device) are designed to restore blood flow by removing clots and using continuous aspiration in patients who are experiencing an acute ischemic stroke within eight hours of symptom onset who are ineligible for intravenous tissue plasminogen activator or who fail IV t-PA therapy.