FDA Device recall Z-0482-2016
MicroCutter Xchange 30 Blue Cartridge, FG-025320
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of MicroCutter Xchange 30 Blue Cartridge, FG-025320 by Cardica, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0482-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-06 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cardica |
| Distribution | AL, CA, CO, FL, GA, IA, MA, MD, MN, NY, OH, PA, RI, TX, WA, WI |
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
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.
Identifiers
| code_info | Lot numbers: 120416D 120521E 120606F 120613B 120621A 120910A 120926H 121005C 121022A 121031A 121119B 121217…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 130619B 130613H 130716C 130815E 130822C 130911C 131003E 131113C 131125D 131212F 140109F 140115D 140127B 140204B 140226J 140304A 140310K 140317B 140325B 140430C 140507B 140604C 140610E 140617H 140624E 140707G 140710D 140715H 140804D 140819B 140828C 140916E 140922C 140926C 141008E 141016E 141103A 141106A 150415D 150625B 150813B 151006G |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0482-2016%22
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