Class 2 Device Recall MicroCutter Xchange 30 Blue Curved Tip Cartridge

• Date Initiated by Firm: November 06, 2015
• Date Posted: December 24, 2015
• Recall Status: Terminated on February 12, 2016
• Recall Number: Z-0483-2016
• Recall Event ID: 72687
• 510(K)Number: K140118 K140170
• Product Classification: Staple, implantable - Product Code GDW
• Product: 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.
• Code Information: Lot numbers: 150309A 150527D 150603F 150617B 150820A 150902A 150909B 150924A.
• Recalling Firm/ Manufacturer: Cardica, Inc.; 900 Saginaw Dr; Redwood City CA 94063-4753
• For Additional Information Contact: Julian Nikolchev; 650-331-7124
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process design
• 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.
• Quantity in Commerce: 568 boxes or 6816 cartridges
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GDW and Original Applicant = CARDICA, INC.