MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and

FDA device recall Z-0483-2016 · posted 2015-12-24 · Terminated

Recall details

Recalling firm

Cardica, Inc.

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.

Action taken

An Urgent: Medical Device Removal letter, dated November 17, 2015, was sent via Fed Ex. The letter identified the affected device, described the reason for the recall, and provided the instructions to be followed. Customers were asked to check their inventory, and remove and quarantine any affected product. The notice should be forwarded to relevant personnel, and the affected product should be returned along with the completed Reply Form. A credit will be issued for any returned product. A sales representative can be contacted with questions.

Root cause

Process design

Status

Terminated

Product code

GDW

Quantity affected

568 boxes or 6816 cartridges

Distribution

Worldwide Distribution -- USA, distributed to the states of Alabama, California, Colorado, Florida, Georgia, Iowa, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, Texas

Date initiated

2015-11-06

Date posted

2015-12-24

Date terminated

2016-02-12

Location

Redwood City, CA

Related 510(k) clearances