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penumbra

FDA: Penumbra recall of some Jet 7 catheters is serious

February 3, 2021 By Danielle Kirsh

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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

Filed Under: Catheters Tagged With: penumbra

The top 10 catheter innovations of 2020

December 28, 2020 By Danielle Kirsh

2020-catheter-innovations

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

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Filed Under: Catheters, Implants, Product Development Tagged With: Boston Scientific, Johnson & Johnson, penumbra, Philips, precardia, ReCor Medical, Revamp Medical, Rist Neurovascular, SoniVie

Penumbra recalls some Jet 7 catheters after 14 deaths

December 15, 2020 By Danielle Kirsh

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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

Filed Under: Catheters Tagged With: penumbra

Penumbra clot-retrieval system gains new FDA nod

November 20, 2020 By Nancy Crotti

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

Filed Under: Catheters Tagged With: penumbra

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