Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue Cartridge

• 2 recalls, same reason

  • Terminated Z-0483-2016 FDA Class II ·initiated 6 Nov 2015
  • Terminated Z-0482-2016 FDA Class II ·initiated 6 Nov 2015

  Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler was associated with incomplete firing of staples, potentially resulting in an incomplete transection or anastomosis of tissue during the surgical procedure.

510(k) Number

K140118 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• C-Port Flexa Distal Anastomosis System

  Class II

  FDA 510(k) K070548 Active Cleared 29 Mar 2007

• Cardica C-Port Flex-a Distal Anastomosis System, Model Fg-000150

  Class II

  FDA 510(k) K073123 Active Cleared 6 Dec 2007

• MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge

  Class II

  FDA 510(k) K151081 Active Cleared 15 Jan 2016

• Modification to Cardica C-Port Xa Distal Anastomosis System

  Class II

  FDA 510(k) K090872 Active Cleared 21 Apr 2009

• Cardica Pas-Port Proximal Anastomosis System, Model Fg-000001

  Class II

  FDA 510(k) K091017 Active Cleared 29 Apr 2009

• Cardica Pas-Port Proximal Anastomosis System

  Class II

  FDA 510(k) K081225 Active Cleared 5 Sep 2008

See all devices from Cardica, Inc. →