Events

Safety Alert for Maestro 4000 Cardiac Ablation System Optional Footswitch Accessory

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-06-25
  • Event Date Posted
    2018-06-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180625a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: boston scientific maestro 4000 cardiac ablation system optional footswitch accessory medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its maestro 4000 cardiac ablation system optional footswitch accessory [upns: m00440000, m0044000d0, m0044000h0, m0044000r0 & m0044000z0]. the manufacturer has received reports of unintended continuation of radiofrequency (rf) energy delivery from the maestro 4000 cardiac ablation system after the foot switch has been released. continuing display of rf delivery parameters and emission of audible tone after foot switch release is indications of unintended rf delivery and may result in life-threatening harm. there was one reported case of conductive pathway injury (heart block) during rf energy delivery which may be associated with this behaviour. according to the manufacturer, it has confirmed the maestro 4000 is meeting performance expectations and that this rare behaviour can be resolved with existing instructions within the operator's manual. if rf energy delivery continues after releasing the foot switch, the affected users should follow the instructions to stop rf energy delivery by pressing the rf power control button on the generator or remote panel. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 25 june 2018.

Device

Maestro 4000 Cardiac Ablation System Optional Footswitch Accessory
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Maestro 4000 Cardiac Ablation System Optional Footswitch Accessory
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    DH