The U.S. Food and Drug Administration (FDA) recently announced that Penumbra is recalling its JET 7 Reperfusion Catheter with Xtra Flex Technology due to the risks that it poses for causing serious injuries and even death in patients who use it. The catheter is typically used for removing clots in stroke patients, but the company recommends that all patients stop using the device and that it be removed from all hospitals and other healthcare facilities.
Two specific catheters are affected by the recall, including:
- The JET 7 Xtra Flex catheter
- The JET 7MAX configuration, including MAX delivery device
However, the recall DOES NOT include the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
The FDA says that it has received more than 200 reports concerning deaths, serious injuries, and malfunctions related to the catheter. Fourteen deaths have been reported and serious injuries such as vessel damage, hemorrhage, and cerebral infarction have also occurred. Some of the device failures associated with the affected catheters include ballooning, expansion, rupture, breakage, or complete separation.
This is a Class I recall, which is the FDA’s most serious type of recall. If you use any of the affected catheters that are involved in this recall, talk to your doctor immediately about your next steps. And if you’ve been injured by it, call the defective medical device lawyers at Ferrer Poirot Feller Daniel today for a free consultation.