medical Class I Updated 2021-01-27

Penumbra Inc. recalls Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penu

Recalled Product

Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.


Hazard / Issue

The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Name: Penumbra JET 7 Reperfusion Catheter Catalog Number: 5MAXJET7 UDI Code: 00815948020955 Lot Number Range: C15558 thru C17703 F87621 thru F101011 H10851
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