“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.
HeartWare HVAD Controller AC Adapter and HeartWare HVAD BatteryController AC Adapter Product Code: 1430XXSerial Numbers: CAC000001 to CAC005796 HVAD BatteryProduct Code: 1650XX and A00035 Serial Numbers: BAT000001 to BAT199999ARTG Number: 181875