UPDATE:

• As of Jan. 29, 2021, over 22,600 defective Penumbra JET 7 Xtra Flex catheters have been voluntarily recalled.
• On Feb. 23, 2021, Penumbra, Inc. reported its 2020 fourth-quarter and full-year financial results. The report explicitly states that it excluded the financial impact of the voluntary recall in their results.

Penumbra issued a voluntary recall of their JET 7 Xtra Flex catheter in December 2020 after more than 200 reports of serious injury and death associated with the defective Penumbra device. Over 22,600 catheters have been voluntarily recalled as of January 2020.

According to the U.S. Food and Drug Administration, hundreds of reports were filed with the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database, including instances of serious injuries and even 14 patient deaths associated with the Penumbra catheter leading up to the JET 7 Xtra Flex catheter voluntary recall.

The catheter defect documented in these reports includes ballooning, expansion, rupture, breakage, complete separation, and exposure of the catheter’s internal support coils near the device’s tip. These problems reportedly led to serious adverse events such as vessel damage, hemorrhage, and inadequate blood supply to the brain.

Safety reports from doctors quickly gained attention from the medical community and consumer advocates who called for the device to be recalled. The issue even drew the attention of legal experts who learned that patients may have been seriously injured as a result of the catheter defect.

In July 2020, Penumbra issued a notification to healthcare providers warning them not to inject contrast through the catheter device or use other manufacturers’ revascularization devices. According to the company, this could result in distal tip weakening and eventual expansion or rupture leading to patient injuries and death.

Although the company sent this notification out earlier this year, the FDA has reportedly continued to receive MAUDE reports surrounding the catheter defect. As a result, the agency asked Penumbra to recall their device voluntarily and the manufacturer complied with this request.

“Since Penumbra’s labeling update and Notification to Healthcare Providers, the FDA continues to receive new MDRs related to the same device failure modes, including some reports where the updated instructions were not followed by health care providers,” the FDA revealed in their catheter defect recall announcement.

“Because of the persistent risk, the FDA requested that Penumbra voluntarily remove the JET 7 Xtra Flex from the market to protect patients.“

On Feb. 23, 2020, Penumbra, Inc. released its 2020 fourth-quarter and annual financial report. While the company boasted an increase of 14.9 percent in revenue throughout the fourth quarter, it explicitly notes that many of the reported financial highlights “exclud[e] the impact of the December 15, 2020, voluntary recall of the Jet 7 Reperfusion Catheter with Xtra Flex technology.”

What Was the Penumbra JET 7 Catheter Device Used For?

The Penumbra catheter was indicated for patients within eight hours of acute ischemic stroke symptom onset who were ineligible for drug revascularization using intravenous tissue plasminogen activator medications or whose symptoms don’t improve after medication-induced revascularization.

Unfortunately, according to the FDA’s recall alert, the Penumbra catheter defect reportedly causes the device to be unfit to perform in its intended purpose.

Testing by the manufacturer reportedly revealed that the JET 7 Xtra Flex catheter cannot withstand the burst pressure to failure as those withstood by Penumbra’s other large bore aspiration catheters. These tests involved plugging the catheter’s distal tip and pressurizing the device to failure.

Due to these test results and reports of the catheter defect causing injuries and deaths, Penumbra initiated a voluntary recall of their product on Dec. 15. The Penumbra catheter recall includes the following devices:

• The JET 7 Xtra Flex catheter.
• The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device).

The Penumbra JET 7 Reperfusion Catheter with a Standard Tip is not included in the recall.

Healthcare providers and hospitals who have the recalled devices on hand are directed to stop using these catheters and remove unused products from their inventory. Providers can then fill out Penumbra’s product identification/return form and return the products to the manufacturer according to their instructions. Any related adverse events can be reported to the FDA’s MAUDE database.

“Penumbra remains committed to consistently provide medical products that meet the requirements and expectations of our customers while maintaining compliance with all applicable regulations,” Penumbra said in a recall announcement. “We appreciate your prompt attention and cooperation in this matter.”

Unfortunately, this is not the first Penumbra catheter to be recalled due to defects. In 2017, Penumbra recalled their Penumbra 3D Revascularization Device which was designed to be used during revascularization in acute ischemic stroke patients.

According to the recall announcement, the device’s delivery wire could break or separate during use. As a result, fractured pieces of the delivery wire could end up inside the patient’s brain. These debris and subsequent attempts to retrieve the fragments could reportedly lead to worsening stroke symptoms and other adverse consequences such as further blood vessel blockages and death.