Events

Recall of ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a left ventricular pacing lead)

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-01192-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01192-1
  • 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
    Boston scientific is recalling certain lots of 9fr acuity pro coronary sinus outer guide catheters due to potential for separation of the proximal handle from the shaft. boston scientific's investigation concluded that if the hub and shaft are aligned off-centre in the bonding equipment during manufacturing, the result may be a reduced bond, which may separate during cutting. the affected products were manufactured during the time period when the equipment was likely to be misaligned.The most serious injury foreseeable with unexpected hub detachment is a moderate delay in the procedure to reposition a dislodged lead. boston scientific has received reports of handle separations during the cut and removal process; there have been no reports of patient harm.
  • Action
    Customers are advised to immediately segregate all affected products to ensure that it will not be used and to ship the stock back to Boston Scientific for replacement with unaffected stock. This action has been closed-out on 24/08/2016.

Device

ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a...
  • Model / Serial
    ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a left ventricular pacing lead)Model Numbers: 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119Multiple Lot Numbers affectedARTG Number: 222220
  • 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