Z-0482-2016Class II

MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter...

Name: Z-0482-2016 MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter...
Creator: Cardica, Inc.
Published: 2015-11-06
License: https://open.fda.gov/license/

Cardica, Inc. / initiated 2015-11-06 / Terminated / root cause: manufacturing process

FDA source

Cardica, Inc. began a recall of MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L... on 2015-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0482-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-06
Posted: 2015-12-24
Terminated: 2016-02-12
Recalling firm: Cardica, Inc.
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.
Product code: GDW Staple, Implantable
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0482-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0482-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24
Z-0483-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24

Product code GDW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)