A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said. The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related to the … [Read more...] about FDA: Penumbra recall of some Jet 7 catheters is serious
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The top 10 catheter innovations of 2020
As the COVID-19 pandemic took over the world in 2020, medical device companies continued to showcase new catheter innovations. Throughout 2020, we saw FDA clearances, approvals and product launches for a variety of catheter-based technologies, including renal denervation systems, heart failure treatment catheters, mechanical thrombectomy systems … [Read more...] about The top 10 catheter innovations of 2020
Penumbra recalls some Jet 7 catheters after 14 deaths
Penumbra (NYSE:PEN) has issued an urgent voluntary recall of all configurations of its Jet 7 Reperfusion Catheters with Xtra Flex Technology because the catheter may become susceptible to distal tip damage during use. So far, Alameda, Calif.-based Penumbra has received 14 reports of death related to the problem out of the more than 30,000 … [Read more...] about Penumbra recalls some Jet 7 catheters after 14 deaths
Penumbra clot-retrieval system gains new FDA nod
Penumbra (NYSE:PEN) announced today that the FDA has granted expanded clearance for its Indigo aspiration catheter system, Lightning 12. Indigo Lightning is now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism, according to … [Read more...] about Penumbra clot-retrieval system gains new FDA nod
