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U.S. Department of Health and Human Services

Class 2 Device Recall MicroCutter XCHANGE 30

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  Class 2 Device Recall MicroCutter XCHANGE 30 see related information
Date Initiated by Firm November 06, 2015
Date Posted December 24, 2015
Recall Status1 Terminated 3 on February 12, 2016
Recall Number Z-0482-2016
Recall Event ID 72687
510(K)Number K132581  K140118  K140170  
Product Classification Staple, implantable - Product Code GDW
Product MicroCutter Xchange 30 Blue Cartridge, FG-025320;
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.

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: 120416D 120521E 120606F 120613B 120621A 120910A 120926H 121005C 121022A 121031A 121119B 121217F 130131A 130207A 130213A 130220H 130227C 130307B 130320A 130328A 130426A 130508A 130516A 130619B 130613H 130716C 130815E 130822C 130911C 131003E 131113C 131125D 131212F 140109F 140115D 140127B 140204B 140226J 140304A 140310K 140317B 140325B 140430C 140507B 140604C 140610E 140617H 140624E 140707G 140710D 140715H 140804D 140819B 140828C 140916E 140922C 140926C 141008E 141016E 141103A 141106A 150415D 150625B 150813B 151006G  
Recalling Firm/
Cardica, Inc.
900 Saginaw Dr
Redwood City CA 94063-4753
For Additional Information Contact Julian Nikolchev
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 2
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.