Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0482-2016 — 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 MicroCut

U.S. FDA — Device Enforcement · United States · 2015-11-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0482-2016
Date of alert: 2015-11-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardica, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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