Events

Recall of IMAGER II CATHETER GEN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BOSTON SCIENTIFIC 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
    38427
  • Event Risk Class
    III
  • Event Initiated Date
    2016-12-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Boston scientific is initiating a product advisory for a subset of imagert ii angiographic catheters. following a field report boston scientific has determined that some units within a single lot were missing the bottom pouch seal. this was caused by an alternate label reprint process which resulted in the units missing a step in the packaging process. although boston scientific has confirmed that only one batch was missing a bottom seal as a precautionary measure we are notifying all customers of this issuethat received batches processed through this alternate label reprint process.

Device

IMAGER II CATHETER GEN
  • Model / Serial
    Model Catalog: 31-450 (Lot serial: 113080); Model Catalog: 31-415 (Lot serial: 111817); Model Catalog: 31-489 (Lot serial: 113932); Model Catalog: 31-415 (Lot serial: 112429); Model Catalog: 31-414 (Lot serial: 112429); Model Catalog: 31-414 (Lot serial: 111817); Model Catalog: 31-482 (Lot serial: 111870); Model Catalog: 31-467 (Lot serial: > 10 lots contact MFG); Model Catalog: 31-466 (Lot serial: > 10 lots contact MFG); Model Catalog: 31-463 (Lot serial: > 10 lots contact MFG); Model Catalog: 31-462 (Lot serial: > 10 lots contact MFG); Model Catalog: 31-525 (Lot serial: 112122); Model Catalog: 31-532 (Lot serial: 114731); Model Catalog: 31-525 (Lot serial: 114731); Model Catalog: 31-532 (Lot serial: 112650); Model Catalog: 31-525 (Lot serial: 112650); Model Catalog: 31-532 (Lot serial: 112122); Model Catalog: 31-667 (Lot serial: > 10 lots contact MFG); Model Catalog: 31-476 (Lot serial: 112764); Model Catalog: 31-435 (Lot serial: > 10 lots contact MFG); Model Catalog: 31-433 (Lot serial: > 10 lots contact
  • Product Description
    IMAGER II CATHETER GEN;IMAGER II CATHETER H;IMAGER II CATHETER RDC;IMAGER II CATHETER SHK;IMAGER II CATHETER C;IMAGER II CATHETER CONTRALATERAL;IMAGER II CATHETER MIK;IMAGER II CATHETER SIM;IMAGER II CATHETER BARNH;IMAGER II CATHETER STRAIGHT;IMAGER II CA
  • Manufacturer
    BOSTON SCIENTIFIC LTD.

Manufacturer

BOSTON SCIENTIFIC LTD.
  • Manufacturer Address
    MISSISSAUGA
  • 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
    HC