JET 7 Catheters with Xtra Flex Technology can cause hemorrhage, death.
Tuesday, December 22, 2020 - Medical device maker Penumbra has issued an urgent warning and recall of catheters used to remove blood clots in stroke patients. JET 7 Catheters with Xtra Flex Technology have been tied to 14 deaths and 11 injuries, and have been indefinitely and immediately removed from the U.S. market.
The U.S. FDA has received more than 200 adverse event reports regarding the catheters, some involving deaths and others involving serious injury or malfunction. Patients have suffered hemorrhage, vessel damage, strokes, and have died due to their injuries.
The catheters have repeatedly failed while in use. The FDA has received reports of ballooning, expansion, rupture, breakage or complete separation, and exposure of coils inside the tip of the JET 7 Xtra Flex catheter.
Tests performed by Penumbra found that the JET 7 Xtra Flex catheter did not perform as expected compared to other catheters used to treat blood clots in acute ischemic stroke patients.
Penumbra has issued a voluntary recall of more than 30,000 units. So far, Penumbra is aware of 17 patient injuries and 14 deaths caused by distal tip damage and expansion and rupture following contrast injection. There were also 11 patient injuries not related to distal tip damage.
The recall involves:
- JET 7 Xtra Flex catheter
- JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device)
Unique Device Identifier (UDI) numbers of the devices are 00815948020962, 00815948021594 and 00815948020955.
Penumbra JET 7 Reperfusion Catheter with Standard Tip is not included in the recall.
Medical professionals are asked to stop using these devices immediately.
If you or a loved one was injured or died following the failure of a JET 7MAX with Xtra Flex Technology catheter, contact the defective medical device attorneys at OnderLaw at 800-RxWatch (800-799-2824). We hold corporations accountable for putting profits over patient safety.
Call OnderLaw at 800-799-2824 for a free, no-cost consultation. We will review information and let you know if you are eligible for compensation. We donít get paid unless you win your case, and we will fight for you.
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