Device recall: MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30…
Class II FDA enforcement event 72687. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Cardica, Inc. started this device recall on 6 Nov 2015. The firm address in the FDA record is in Redwood City, CA. FDA put the recall in Class II. FDA event 72687 has 2 product records. The first FDA enforcement report date is 30 Dec 2015. The record gives the status Terminated, with the termination date 12 Feb 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution -- USA, distributed to the states of Alabama, California, Colorado, Florida, Georgia, Iowa, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island,…
Recalling firm
Cardica, Inc., Redwood City, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0482-2016 | 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… | 568 boxes or 6816 cartridges | Class II | Terminated | 30 Dec 2015 |
| Z-0483-2016 | 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… | 568 boxes or 6816 cartridges | Class II | Terminated | 30 Dec 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 2
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0482-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 72687. https://recallregister.com/fda/ii/72687/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution -- USA, distributed to the states of Alabama, California, Colorado, Florida, Georgia, Iowa, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island,…
- What quantity of product is in FDA event 72687?
- The event has 2 product records. The first record gives this quantity:
568 boxes or 6816 cartridges
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.