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.
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Manufacturer received customer report of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. manufacturer has evaluated all in-house inventories and the expected defect rate is extremely small. as a precautionary measure manufacturer is conducting a voluntary recall to notify customers of the potential of this packaging defect. manufacturer has not received any reports of patient harm or infection attributed to this issue however invasive medical procedures conducted using non-sterile products could result in an infection for the patient.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.