Penumbra: Data Shared with FDA in Early June Showed Increase in Jet 7 Injuries and Deaths Attributed to Contrast Injection, But Company Did Not Warn Doctors Until Late July

Published on Aug 30, 2021

On May 27, 2020, the Food and Drug Administration wrote to Penumbra (PEN) that it was “evaluating a potential post-market safety concern associated with use of the Penumbra JET 7 and 7X Reperfusion Catheters,” which are used to clear blood clots in the brains of stroke patients. Citing “reported distal tip fractures, breakages, ruptures, expansion/ballooning” […]

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