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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This voluntary recall is being conducted following six customer reports of the ceramic trocar tip of the emprint ablation antenna disengaging from the needle shaft post-ablation. tip disengagement can result in the ceramic trocar tip remaining in the patient presenting a risk of latent migration and potential damage to adjacent tissue.
Model Catalog: CA30L2 (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: CA15L1 (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: CA20L1 (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: CA30L1 (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: CA15L2 (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: CA20L2 (Lot serial: > THAN 10 CONTACT MFR)
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EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSHERE TECHNOLOGY
“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.