Events

Recall of Device Recall Boston Scientific TSX Transseptal Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merit Medical Systems, Inc..

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
    73630
  • Event Risk Class
    Class 2
  • Event Number
    Z-1375-2016
  • Event Initiated Date
    2016-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144636
  • 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
    Trocar - Product Code DRC
  • Reason
    Merit medical systems, inc. is voluntarily conducting a recall of one lot of the tsx" transseptal needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. the curve dimensional values on the labels of this lot incorrectly indicate a 50¿ curve, rather than the correct 86¿ curve.
  • Action
    The consignee was provided verbal and written notification of the field action on March 15, 2016. There was a total of one (1) consignee, an OEM customer in the USA, who received 25 units. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue distribution, and instructions to initiate a product recall in accordance with their company's established policies for customers to whom they shipped the affected Merit product. An email notification was sent to the Merit sales representative of the affected account. The sales representative was provided a Customer Response Form applicable to their account. The sales representative was instructed to assist the account with the completion of the Customer Response Form and the return of the affected units back to the Merit Field Assurance Department.

Device

Device Recall Boston Scientific TSX Transseptal Needle
  • Model / Serial
    Lot Q823423, Exp 7/31/2018
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to one customer in the US.
  • Product Description
    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; || Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA