FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of v

FDA device recall Z-2126-2014 · posted 2014-07-29 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

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.

Action taken

Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) sent an Urgent Medical Device Recall letter on July 11, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that the recall is being conducted as a precautionary measure due to the 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. The recall letter informs the customers of the safety risk and and actions to be taken. Customers with questions about the recall are instructed to contact the Synovis MCA Customer Service unit at (800) 510-3318 or (205) 941-0111.

Root cause

Process control

Status

Terminated

Product code

DPW

Quantity affected

1,315 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.

Date initiated

2014-07-11

Date posted

2014-07-29

Date terminated

2015-05-27

Location

Westlake Village, CA

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