A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said.
The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related to the device. Penumbra distributed the devices between June 17, 2019 and Dec. 14, 2020.
Some Jet 7 catheters pose 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 said in December that it received over 200 medical device reports associated with the catheter, which included deaths, serious injuries and malfunctions, according to the FDA letter warning healthcare providers. The FDA at the time said 20 of the MDRs described 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.
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.
The recall followed 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.