Events

Safety Alert for Atlantis PV 15 MHz Peripheral Imaging Catheter

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
    2014-01-17
  • Event Date Posted
    2014-01-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140117.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 atlantis pv 15 mhz peripheral imaging catheter medical device manufacturer, boston scientific, has issued a medical device safety alert concerning atlantis pv 15 mhz peripheral imaging catheter. details of affected products are as follows: material number (upn): h749364560 catalogue number: 36456 lot numbers: 16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530 expiration date: 11 jun 2014 to 29 oct 2014 the manufacturer has become aware that the manifold of certain lots may be blocked by excess bonding adhesive. a blocked manifold may prevent affected catheter from advancing over the guidewire resulting in a delay in procedure while the device is exchanged for another unit. the manufacturer advises users to discontinue the use of and segregate the recalled product immediately. the product should be returned to the manufacturer for replacement. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 17january2014.

Device

Atlantis PV 15 MHz Peripheral Imaging Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Atlantis PV 15 MHz Peripheral Imaging Catheter
  • 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