The Food and Drug Administration (FDA) announced today that Penumbra has recalled all units of the Penumbra Reperfusion Catheter with Xtra Flex Technology (Jet 7 Xtra Flex) due to increased risk of serious injury and death while removing blood clots in stroke patients.
The Penumbra Jet 7 catheter recall comes after the FDA received over 200 medical device reports detailing issues with the catheter, including serious injuries such as hemorrhages, blood vessel damage, and death. Twenty of these reports involve patient deaths in procedures in which the catheter was used. The recalled JET 7 Xtra Flex catheter was intended to be used to remove blood clots in the brains of patients who have suffered acute ischemic strokes.
According to the FDA’s recall announcement, Penumbra’s testing found that the distal tip of the Jet 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other catheters also used to remove clots in stroke patients. As a result, the Jet 7 Xtra Flex catheter can balloon, expand, rupture, break, or completely separate in the middle of surgery. Such product failure may lead to catastrophic injuries.
Injuries associated with the Penumbra Jet 7 Xtra Flex Catheter Recall include:
- Brain Bleeds
- Hemorrhagic Strokes
- Blood Vessel Damage
- Death
Contact Goldenberg Lauricella
The catheter recall attorneys at Goldenberg Lauricella are currently representing individuals and the families of individuals who have suffered serious injuries or death due to the Penumbra Jet 7 Xtra Flex catheter. Contact us today for a free Penumbra Jet 7 lawsuit consultation. We have over 30 years of experience litigating defective medical device cases and have recovered tens of millions of dollars for our clients. Let us deliver the Gold standard advocacy you deserve.