Aortic Arch Cannulas

• • Terminated Z-2871-2017 FDA Class II ·initiated 9 Jun 2017

  Identification of excess plastic on the tip of the cannula.

• • Terminated Z-2756-2016 FDA Class II ·initiated 12 Aug 2016

  Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.

• • Terminated Z-2147-2016 FDA Class II ·initiated 22 Jun 2016

  Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.

• • Terminated Z-0813-2016 FDA Class II ·initiated 25 Jan 2016

  Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.

510(k) Number

K943934 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae

  Class II

  FDA 510(k) K972503 Active Cleared 26 Aug 1997

• Xtra

  Class II

  CE/MDR FDA 510(k) K112245 Active Cleared 6 Sep 2011

• XTRA Autotransfusion System (with XTRA Bowl sets)

  Class II

  FDA 510(k) K240584 Active Cleared 29 Apr 2024

• Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating

  Class II

  FDA 510(k) K061527 Active Cleared 27 Jun 2006

• Retrograde Cardioplegia Cannula, Manual-Inflating, with Malleable or Guidwire Stylet

  Class II

  FDA 510(k) K010974 Active Cleared 18 Jun 2001

• PureFlex Arterial Cannulae

  Class II

  FDA 510(k) K180979 Active Cleared 16 Nov 2018

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