The US Food and Drug Administration announced the urgent voluntary recall of Penumbra’s Jet 7 reperfusion catheters Xtra Flex Technology (JET 7 Xtra Flex) due to increased risk of death and injuries.
What the Recall Notification Says
“Penumbra is recalling the JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage,” says Penumbra on its Urgent Voluntary Medical Device Recall Notification.
“Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death,” the company adds.
JET 7 Xtra Flex catheters are a part of the Penumbra system with the Penumbra Aspiration Tubing and Penumbra Aspiration Pump. Healthcare providers and medical professionals use the system to remove blood clots in patients and improve or restore blood flow.
Adverse Reports in Relation to the Recall
The US FDA issued an urgent letter to healthcare providers, informing them of the manufacturer’s recall, noting that the agency has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter. These include 14 unique patient deaths and reports of serious injuries ranging from hemorrhage, to vessel damage, and cerebral infarction.
Recalls in medical devices usually see these types of adverse effects. The Paragard lawsuits have also seen reports and claims about the allegedly faulty medical device, Paragard, wherein aside from a lot of unimaginable physical pain involved, the impact it had in the plaintiffs’ mental health were also too extreme to be described in words.
Penumbra estimates that around 30,000 units of the faulty product have been distributed.
Other device failure modes reported include “expansion, ballooning, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter,” the FDA notice adds.
The recall involves all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex). It does not include the Penumbra Jet 7 Reperfusion Catheter with Standard Tip.
According to the FDA, the impacted devices 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.
Here are the Unique Device Identifier (UDI) numbers provided by Penumbra: 00815948020962, 00815948021594, and 00815948020955.
The company has urgently recalled all lots of the impacted devices. Users were asked to immediately check for specific catalog numbers, remove all units from inventory, and “place them in quarantine for return to Penumbra.”
You can also report any adverse reactions experienced with the JET 7 Xtra Flex through MedWatch, the FDA Safety Information and Adverse Event Reporting Programme.
Not the First in Penumbra’s History
This is not the first time that Penumbra has been involved with issues in damaged and faulty medical devices. Back in 2017, the company issued a recall for its 3D stent retriever, a device used to remove blood clots in the setting of acute ischemic stroke.
It has been recalled because of increased risks of breakage or total separation of the delivery wire, which could be left inside the patient’s brain, wherein “the attempts made to retrieve the fractured pieces can make the stroke worse,” the FDA announcement about the 2017 recall stated.