Commercial Name: Bravo pH Monitoring System / Bravo pH Capsule with Application Device. ANVISA registration number: 10349000438. (Bravo pH Monitoring System) and Capsula Bravo pH with Application Device (10349000435). Risk class: 2. Model (s) affected; and Lot (s) / Serial number (s) affected :. FGS-0312 Bravo® ph capsule delivery device, package with 5. FGS-0313 Bravo® ph capsule delivery device, unit pack
“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.