CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
MicroCutter Xchange 30 Blue Curved Tip Cartridge recalled by Cardica
Cardica is recalling MicroCutter Xchange 30 Blue Curved Tip Cartridge, distributed in 16 states. The recall was initiated on 6 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0483-2016
- FDA event ID
- 72687
- Recalling firm
- Cardica, Redwood City, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2015
- FDA classified
- 24 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 6 Nov 2015 | Recall initiated by company | |
| 24 Dec 2015 | Classified by FDA | +48 days |
| 30 Dec 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
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.
AlabamaCaliforniaColoradoFloridaGeorgiaIowaMassachusettsMarylandMinnesotaNew YorkOhioPennsylvaniaRhode IslandTexasWashingtonWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot numbers: 150309A 150527D 150603F 150617B 150820A 150902A 150909B 150924A.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 72687This product is part of a recall event; the main page for the event is MicroCutter Xchange 30 Blue Cartridge, FG recalled by Cardica.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MicroCutter Xchange 30 Blue Cartridge, FG recalled by Cardica | Cardica | Foreign Material | 16 states |
More recalls from Cardica
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MicroCutter Xchange 30 Blue Cartridge, FG recalled by Cardica | Cardica | Foreign Material | 16 states |
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