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Cardica, Inc.

United StatesFDA applicant, unverified

Devices
15
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue15

Newest first, rows 1-15 of 15

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Rows 1-15 of 15

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2015

    • 6 Nov 2015 Z-0482-2016 Class II Terminated 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. Distribution: Worldwide Distribution -- USA, distributed to the states of Alabama, California, Colorado, Florida, Georgia, Iowa,…
      Full distribution text 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.
      Submission numbers: K132581, K140118, K140170
    • 6 Nov 2015 Z-0483-2016 Class II Terminated 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. Distribution: Worldwide Distribution -- USA, distributed to the states of Alabama, California, Colorado, Florida, Georgia, Iowa,…
      Full distribution text 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.
      Submission numbers: K140118, K140170

Frequently asked questions

How many devices does Cardica, Inc. have in the registry?

The registry currently lists 15 devices for Cardica, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cardica, Inc.'s devices?

Among its 15 most recently registered devices, Cardica, Inc. has devices listed in FDA 510(k) (15 devices).

What risk classes do Cardica, Inc.'s devices fall under?

Among its 15 most recently registered devices, the classes recorded for Cardica, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cardica, Inc.?

FDA recall records list 2 recalls initiated by Cardica, Inc., the most recent initiated on 6 Nov 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Cardica, Inc. in the registry?

The most recently registered devices listed for Cardica, Inc. include C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM, CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150, MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge and MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.