Medtronic Resting Heart System, Model AAR1000 and 711

• • Terminated Z-1919-2008 FDA Unclassified (pre-2012) ·initiated 9 May 2008

  Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).

510(k) Number

K031700 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Affinity 20U Arterial Filter with Trillium Biosurface

  Class II

  FDA 510(k) K033468 Active Cleared 14 Nov 2003

• autoLog IQ Autotransfusion System

  Class II

  FDA 510(k) K181954 Active Cleared 22 Aug 2018

• Eopa 3D Arterial Cannula, Models 78220, 78222, 78320, 783222

  Class II

  FDA 510(k) K061254 Active Cleared 23 Jun 2006

• Bio-Console 560

  Class II

  FDA 510(k) K080824 Active Cleared 7 May 2008

• Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula Tip

  Class II

  FDA 510(k) K020147 Active Cleared 3 Apr 2002

• Bio-Console, Model 560

  Class II

  FDA 510(k) K051303 Active Cleared 10 Jun 2005

See all devices from Medtronic Perfusion Systems →