Home / Recalls / Medical Devices
Baxter Healthcare Corporation recalls FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis o
Recalled August 6, 2014 · FDA recall Z-2126-2014 · Baxter Healthcare
Hazard
Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored. · FDA Class II
Units
1,315 units
Sold at
Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.
Description
Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.
Product
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →