Heartport Endoarterial Return Cannula

• • Terminated Z-1972-2013 FDA Class II ·initiated 16 Jul 2013

  Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.

• 5 recalls, same reason

  • Terminated Z-0307-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003
  • Terminated Z-0310-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003
  • Terminated Z-0308-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003
  • Terminated Z-0309-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003
  • Terminated Z-0311-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003

  Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

510(k) Number

K971291 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Directflow Arterial Cannula

  Class II

  FDA 510(k) K990772 Active Cleared 23 Mar 1999

• Heartport Endosinus Catheter

  Class II

  FDA 510(k) K961270 Active Cleared 18 Jun 1996

• Heartport Needle Trocar

  Class II

  FDA 510(k) K965051 Active Cleared 12 Mar 1997

• Heartport Endopulmonary Vent Catheter

  Class II

  FDA 510(k) K981009 Active Cleared 4 Sep 1998

• Heartport Introducer Sheath

  Class II

  FDA 510(k) K972570 Active Cleared 1 Oct 1997

• Heartport Endopulmonary Vent

  Class II

  FDA 510(k) K961245 Active Cleared 18 Jun 1996

See all devices from Heartport, Inc. →