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
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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