Penumbra Catheter Recall: FDA Issues JET 7 Xtra Flex Warning
In December 2020, the FDA announced an “urgent” Penumbra catheter recall, which includes a recall of the JET 7 Xtra Flex catheter. The recalled catheter is commonly used in thrombectomy procedures in which surgeons remove blood clots following a stroke.
According to the FDA report, the safety agency received over 200 medical device reports (MDRs) associated with the recalled Penumbra catheter, including deaths, serious injuries, and catheter malfunctions. Twenty of the catheter malfunction reports describe 14 patient deaths. Other collected MDRs describe patient injuries that include:
- Blood vessel damage
- Cerebral infarction
Penumbra Catheter failure reports include the ballooning, expansion, rupture, breakage, separation, and exposure of internal support coils of the allegedly defective catheter. In the reports, the tip of the catheter reportedly broke during surgery, causing complications and on occasion leading to patient death.
Joe Lyon is an experienced medical device failure attorney, investigating defective catheter cases and filing surgical error lawsuits. Did you or a loved one suffer a stroke, which resulted in a blood clot? Did you require surgery? Did you suffer and injury or complications due to a defective catheter? Contact The Lyon Firm for a free consultation.
What is a Penumbra Catheter?
Those who suffered hemorrhagic strokes in 2019 may have had an operation in which the recalled Penumbra JET 7 Xtra Flex Catheter was used. The Penumbra catheter recall involves a model that was cleared to market in June 2019, and designed for use in surgery for stroke patients. A hemorrhagic stroke occurs when blood vessels rupture, causing blood to bleed into the brain. To treat patients, revascularization can be performed in an attempt to remove the blood clot.
The recalled Penumbra catheter was used by surgeons in thrombectomy procedures when removing blood clots from veins and arteries.
Are Penumbra Catheters Safe?
Due to recent injury reports, some medical and legal experts are concerned with the safety of certain devices, which may be part of the Penumbra catheter recall announcement. There have been numerous death reports involving the Penumbra catheter according to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database.
In the reports, arterial ruptures occurred in the internal carotid artery, which supplies blood to the brain. Some reported ruptures were associated with damage to the tip of the catheter. At least one patient died after the tip of a Penumbra catheter broke off inside the body during a surgical procedure. When the catheter was removed from the patient, the doctor noted that the coils at the tip of the medical device were “frayed.”
A fracture of the tip of a Penumbra catheter could lead to significant complications, including blood vessel ruptures, hemorrhaging, and death.
Penumbra Catheter Recall
On December 15, Penumbra issued an urgent voluntary recall of their JET 7 Extra Flex catheter. The recall was announced after months of injury reports and internal corporate pressure. Penumbra, Inc. is now warning physicians of the catheter rupture risk when contrast is injected through the catheter. The company is instructing surgeons not to use the JET7 Xtra Flex catheter for this purpose.
Penumbra has had to recall products in the past as well. In 2007, Penumbra recalled their 3D Revascularization device due to concerns that the device’s delivery wire could break during surgery, potentially leaving fractured pieces of the device in a patient’s brain.
Can I File a Defective Catheter Lawsuit?
You may qualify for a defective catheter claim if you or a loved one suffered a hemorrhagic stroke that required surgery to clear a blood clot, and subsequently suffered an injury or death.
If you or a loved one suffered an injury during a procedure involving the Penumbra JET 7 Xtra Flex catheter, contact The Lyon Firm to discuss a possible defective medical device case. A nationwide defective device investigation is open to any patient whose surgical procedure led to a secondary injury, infection of complication.