Cardica Recalls MicroCutter Xchange 30 Blue Cartridges Due to Firing Defect
Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Cartridges because they may fail to fire staples completely, potentially causing incomplete tissue transection or anastomosis during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural failure of a surgical device (incomplete staple firing) that directly risks significant injury to patients during surgery, fitting the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Cardica, Inc. is recalling the MicroCutter Xchange 30 Blue Cartridge and MicroCutter Xchange 30 Blue Curved Tip Cartridge. These medical devices contain 316L stainless steel staples and are used with the MicroCutter Xchange 30 Stapler, a single-patient device designed for open or minimally invasive surgical procedures involving the small and large intestine and appendix.
The recall was initiated after Cardica, Inc. received reports that using the Blue Cartridges with the MicroCutter Xchange 30 Stapler was associated with incomplete firing of staples. This defect potentially results in an incomplete transection or anastomosis of tissue during the surgical procedure.
The affected products were distributed worldwide, including in the United States and various countries in Europe and the Middle East. The recall involves 568 boxes or 6,816 cartridges across multiple lot numbers. Healthcare providers and facilities should stop using these cartridges and contact Cardica, Inc. for further instructions.
The recalled product
- 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…
- Manufacturer
- Cardica, Inc.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cardica, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Cardica, Inc.
See all →- SevereCardica Recalls MicroCutter Xchange 30 Blue Curved Tip Cartridges
FDA (Devices) · 2015-12-30
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