Flexible Arterial Cannulae

• • Terminated Z-2095-2014 FDA Class II ·initiated 23 May 2014

  During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

• 6 recalls, same reason

  • Terminated Z-0670-2013 FDA Class II ·initiated 7 Jan 2013
  • Terminated Z-0669-2013 FDA Class II ·initiated 7 Jan 2013
  • Terminated Z-0668-2013 FDA Class II ·initiated 7 Jan 2013
  • Terminated Z-0671-2013 FDA Class II ·initiated 7 Jan 2013
  • Terminated Z-0667-2013 FDA Class II ·initiated 7 Jan 2013
  • Terminated Z-0666-2013 FDA Class II ·initiated 7 Jan 2013

  Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.

• 4 recalls, same reason

  • Terminated Z-1838-2012 FDA Class II ·initiated 9 May 2012
  • Terminated Z-1835-2012 FDA Class II ·initiated 9 May 2012
  • Terminated Z-1836-2012 FDA Class II ·initiated 9 May 2012
  • Terminated Z-1837-2012 FDA Class II ·initiated 9 May 2012

  During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti

• • Terminated Z-0200-06 FDA Unclassified (pre-2012) ·initiated 12 Sep 2005

  There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.

510(k) Number

K771499 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Monitor Kits, Blood Level

  Class II

  FDA 510(k) K781145 Active Cleared 27 Jul 1978

• 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System

  Class II

  FDA 510(k) K950739 Active Cleared 17 Nov 1995

• Battery Operated Flow Rate Computer

  Class II

  FDA 510(k) K760756 Active Cleared 15 Oct 1976

• Centrifugal Pump System Lx/Dx Version

  Class II

  FDA 510(k) K882758 Active Cleared 13 Oct 1988

• Clear Cardioplejia Delivery System

  Class II

  FDA 510(k) K823451 Active Cleared 14 Jan 1983

• Sarns Filtered Cardiotomy Reservoir

  Class II

  FDA 510(k) K860702 Active Cleared 28 May 1986

See all devices from 3M Health Care, Sarns →