Events

Recall of Device Recall MicroCutter Xchange 30 Blue Curved Tip Cartridge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardica, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72687
  • Event Risk Class
    Class 2
  • Event Number
    Z-0483-2016
  • Event Initiated Date
    2015-11-06
  • Event Date Posted
    2015-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141983
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Staple, implantable - Product Code GDW
  • Reason
    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.
  • Action
    An Urgent: Medical Device Removal letter, dated November 17, 2015, was sent via Fed Ex. The letter identified the affected device, described the reason for the recall, and provided the instructions to be followed. Customers were asked to check their inventory, and remove and quarantine any affected product. The notice should be forwarded to relevant personnel, and the affected product should be returned along with the completed Reply Form. A credit will be issued for any returned product. A sales representative can be contacted with questions.

Device

Device Recall MicroCutter Xchange 30 Blue Curved Tip Cartridge
  • Model / Serial
    Lot numbers:  150309A 150527D 150603F 150617B 150820A 150902A 150909B 150924A.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, distributed to the states of Alabama, California, Colorado, Florida, Georgia, Iowa, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin ; and, to the countries of Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, Netherlands and United Kingdom, Switzerland, and Qatar.
  • Product Description
    MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; || The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. The staple line length is 30 mm long. The Stapler can be loaded, fired, and reloaded with the MicroCutter XCHANGE 30 Cartridge for up to the number deployments indicated on package label in a single surgical procedure. The Stapler can fire different sized staples, with the size of the staple indicated by the color of the MicroCutter XCHANGE Cartridges. || Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.
  • Manufacturer
    Cardica, Inc.

Manufacturer

Cardica, Inc.
  • Manufacturer Address
    Cardica, Inc., 900 Saginaw Dr, Redwood City CA 94063-4753
  • Source
    USFDA