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 device. Penumbra distributed the devices between June 17, 2019 and Dec. 14, 2020.
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