Baxter Healthcare Corporation: 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.

Recall number

Z-2126-2014

Recalling firm

Baxter Healthcare Corporation

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.

Status

Terminated

Initiated

2014-07-11

Posted

2014-07-29

Terminated

2015-05-27

Reason

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.

Root cause

Process control

Action

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.

Quantity

1,315 units

Distribution

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

Lot, serial or model codes

Lot Number SPSGT14-02B0027a SPSGT14-04D0005 SPSGT14-04D0023  SPSGT13-10J0016 SPSGT13-11K0041 SPSGT13-12L0008 SPSGT14-01A0009  SPSGT14-02B0026 SPSGT14-04D0015 SPSGT14-04D0026  SPSGT13-10J0017 SPSGT13-11K0039 SPSGT13-11K0042 SPSGT13-12L0015 SPSGT14-01A0028  SPSGT14-02B0028 SPSGT14-02B0033 SPSGT14-04D0014 SPSGT14-04D0027 SPSGT14-05E0005  SPSGT13-10J0018 SPSGT13-11K0040 SPSGT13-12L0007 SPSGT13-12L0012 SPSGT14-01A0027   Part No. 5151-01200-010 5151-01200-010 5151-01200-010   5151-01200-011 5151-01200-011 5151-01200-011 5151-01200-011   5151-01250-010 5151-01250-010 5151-01250-010   5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011   5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010   5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011

510(k) numbers

["K132727"]

PMA numbers

not on file

Product code

DPW

Firm FEI

3000121413

Firm city

Westlake Village

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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