Z-2126-2014Class II

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

Name: Z-2126-2014 FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end...
Creator: Baxter Healthcare Corporation
Published: 2014-07-11
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-07-11 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of 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... on 2014-07-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2126-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-11
Posted: 2014-07-29
Terminated: 2015-05-27
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.
Product code: DPW Flowmeter, Blood, Cardiovascular
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1,315 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2126-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2126-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-29

Product code DPW

K132727Class IIGem Flow Coupler Device and SystemSynovis Life Technologies, Inc. / cleared 2013-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)