Events

Recall of WATCHMAN Left Atrial Appendage Closure Device with Delivery System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific Pty Ltd.

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
    RC-2015-RN-00815-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-08-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00815-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Bsc has identified that cross-threading of the hemostasis valve may occur if the valve is tightened with the dilator in place, potentially preventing subsequent sealing of the valve when desired.This product correction reinforces existing directions for use (dfu) and provides further guidance regarding the correct use of the hemostasis valve in order to avoid cross-threading and to securely seal the valve, minimising the potential for undesirable blood leakage during surgery.
  • Action
    Boston Scientific is providing implanting surgeons with additional instruction to ensure that the risk of cross-threading of the hemostasis valve is mitigated. The product instruction for use are also being updated with this information.

Device

WATCHMAN Left Atrial Appendage Closure Device with Delivery System
  • Model / Serial
    WATCHMAN Left Atrial Appendage Closure Device with Delivery SystemMaterial Numbers: M635WC21060, M635WC24060, M635WC27060, M635WC30060, M635WC33060, M635WS21060, M635WS24060, M635WS27060M635WS30060, M635WS33060, M635WU21060, M635WU24060, M635WU27060, M635WU30060, M635WU33060WATCHMAN Access System Access Sheath with DilatorMaterial Numbers: M635TC10060, M635TC20060, M635TS10060, M635TS20060, M635TS40060, M635TU10060, M635TU20060, M635TU40060ARTG Numbers: 216434 and 216435
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA