“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 Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)Catalogue Numbers: 1100, 1101, 1102, 1103, 1104 & 1205Serial Numbers: HW001 to HW11215 and HW20001 to HW20296ARTG Number: 181875
HeartWare Ventricular Assist System batteriesProduct code: 1650Serial number range for the affected batteries: BAT000001 to BAT039999; BAT090000 to BAT099999ARTG number:181875