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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Medtronic is initiating a voluntary recall on specific lots of solarice rapid exchange balloon dilation catheter due to reports of stylette removal difficulties. in the event that stylette removal difficulties are encountered there is the potential for damage to the balloon or catheter due to excessive force being applied and this may lead to balloon inflation or deflation challenges. potential risks associated with balloon inflation and deflation difficulties include prolonged procedure time and the need for additional intervention. in addition inflation or deflation difficulties or catheter damage during procedural use could result in vessel occlusion or injury.
“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.