Recall Z-0849-2021— Penumbra Inc.

Name: FDA recall Z-0849-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-15

Class I · Terminated

Class I FDA medical device recall by Penumbra Inc., initiated 2020-12-15, terminated 2024-05-14. It names 3 FDA 510(k) clearances: K202251, K191946, K190010. Product: Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT 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.. Reason: 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..

Recalling firm: Penumbra Inc.
Classification: Class I
Status: Terminated
Initiated: 2020-12-15
Terminated: 2024-05-14
Firm location: Alameda, CA, United States

510(k) clearances named in this recall

3 on FDA's record

K202251 — Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)Penumbra, Inc.·cleared 2020-08-31
K191946 — Penumbra System Penumbra JET 7XPenumbra, Inc.·cleared 2020-02-27
K190010 — Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.·cleared 2019-06-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT 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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.