Cardica Recalls MicroCutter Xchange 30 Blue Curved Tip Cartridges
Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Curved Tip Cartridges because incomplete staple firing may result in 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 and involves a surgical device malfunction that can lead to incomplete tissue transection or anastomosis, which constitutes a significant injury risk.
Plain-English summary
Cardica, Inc. is recalling the MicroCutter Xchange 30 Blue Curved Tip Cartridge (Model Number: FG-025321). The recall involves 568 boxes, or 6,816 cartridges, distributed worldwide to the United States and several countries in Europe and the Middle East. The affected lot numbers are 150309A, 150527D, 150603F, 150617B, 150820A, 150902A, 150909B, and 150924A.
The recall was initiated after reports indicated that using the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler was associated with incomplete firing of staples. This malfunction potentially results in an incomplete transection or anastomosis of tissue during surgical procedures. The cartridges are designed for use in open or minimally invasive surgeries involving the small and large intestine or appendix.
Healthcare facilities and distributors should stop using the affected cartridges and contact Cardica, Inc. for further instructions on the recall process.
The recalled product
- Product
- 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…
- 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 Cartridges Due to Firing Defect
FDA (Devices) · 2015-12-30
Same hazard · surgical device malfunction
See all →- SevereIntuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13
- HighLumbar Interbody Fusion Curette Recalled for Potential Blade Shearing
FDA (Devices) · 2024-05-08
- HighEndoscopic surgical graspers recalled for potential rotation knob cracking
FDA (Devices) · 2023-08-23
Similar recalls
- HighTri-Staple 2.0 surgical stapler cartridge damage may cause incomplete stapling
FDA (Devices) · 2024-06-05
- SevereCustomed Recalls Cardiovascular Case Carts Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereRecall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure
FDA (Devices) · 2021-04-21
- SevereIntuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13
- ModerateMedComp Recalls Split Cath III Trays Due to Incorrect Length Labeling
FDA (Devices) · 2014-09-10
- SevereCustomed Cardiovascular Case Cart Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10