FDANovember 6, 2015device
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 MicroC...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
cardica
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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