LUCAS 2 Chest Compression Systems. Serial Nos.: 30090016 through 30101932
Units distributed between April 2009 and December 2010.
Serial numbers starting with 30101200 and higher have been observed to be more likely to experience this issue and servicing devices in this serial number range will be prioritized.
“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.