MicroCutter Xchange 30 Blue Cartridge — Class II medical device recall Z-0482-2016
Terminated recall by Cardica, Inc., reported 2015-12-30, distributed in AL, CA, CO, FL, GA, IA, MA, MD…. Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler was
| Recall number | Z-0482-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardica, Inc., Redwood City, CA, United States |
| Recall initiated | 2015-11-06 |
| Classified | 2015-12-24 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-02-12 |
| Distributed | AL, CA, CO, FL, GA, IA, MA, MD, MN, NY, OH, PA, RI, TX, WA, WI |
| Countries outside the US | AT, BE, CH, DE, FR, GB, IE, IT, LU, NL, QA |
| Lot numbers | 120416D, 120521E, 120606F, 120613B, 120621A, 120910A, 120926H, 121005C, 121022A, 121031A, 121119B, 121217F, 130131A, 130207A, 130213A, 130220H, 130227C, 130307B, 130320A, 130328A, 130426A, 130508A, 130516A, 130613H, 130619B, 130716C, 130815E, 130822C, 130911C, 131003E, 131113C, 131125D, 131212F, 140109F, 140115D, 140127B, 140204B, 140226J, 140304A, 140310K and 25 more |
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 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. 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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.