Quickdraw Venous Cannula

• • Terminated Z-0800-2020 FDA Class II ·initiated 27 Nov 2019

  If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.

• • Terminated Z-1542-2013 FDA Class II ·initiated 14 May 2013 ·on shared 510(k) K981995

  Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K981995 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K990772 Active Cleared 23 Mar 1999

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  FDA 510(k) K961245 Active Cleared 18 Jun 1996

See all devices from Heartport, Inc. →