Events

Recall of Device Recall FlowCOUPLER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68789
  • Event Risk Class
    Class 2
  • Event Number
    Z-2126-2014
  • Event Initiated Date
    2014-07-11
  • Event Date Posted
    2014-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128666
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Flowmeter, blood, cardiovascular - Product Code DPW
  • 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.
  • 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.

Device

Device Recall FlowCOUPLER
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.
  • Product Description
    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
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • Manufacturer Address
    Baxter Healthcare Corporation, 1 Baxter Way, Westlake Village CA 91362-3889
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA